639:(FDA) approved biological product. The BPCI Act is similar, conceptually, to the Drug Price Competition and Patent Term Restoration Act of 1984 (also referred to as the "Hatch-Waxman Act") which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act). The BPCI Act aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. The FDA has released a total of four draft guidelines related to biosimilar or follow-on biologics development. Upon the release of the first three guidance documents the FDA held a public hearing on May 11, 2012.
182:
Healthcare Act. But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an "interchangeable" may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. The FDA said its approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates
274:
Biosimilars are required to undergo pharmacovigilance (PVG) regulations as its reference product. Thus biosimilars approved by the EMA are required to submit a risk management plan (RMP) along with the marketing application and have to provide regular safety update reports after the product is in the market. The RMP includes the safety profile of the drug and proposes the prospective pharmacovigilance studies.
297:(INN), but is proposed to be managed under the same registry. The report 1 of the May 2017 WHO Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products, published in October 2017, revealed on page 4, that following the outcome arising from the meeting: "No consensus was reached on whether WHO should continue with the BQ... WHO will not be proceeding with this at present."
337:(HTA), specifically cost-effectiveness analysis (CEA) and budget impact analysis (BIA), when manufacturers seek to extend reimbursement indications beyond those of the originator. Additionally, experts proposed that the first biosimilar, offering a minimum 50% discount compared to the originator, be granted immunity from removal from the formulary for a specified period.
343:: The study highlighted the need for policies that enhance both prescriber and patient acceptance of biosimilars. Strategies include disseminating educational materials, implementing financial incentives for prescribing biosimilars as first-line therapy, and using co-payments to encourage the choice of less expensive biosimilars over more costly biologics.
148:(FDA) held that new legislation was required to enable them to approve biosimilars to those biologics originally approved through the PHS Act pathway. Additional Congressional hearings have been held. On March 17, 2009, the Pathway for Biosimilars Act was introduced in the House. Since 2004 the FDA has held a series of public meetings on biosimilars.
7476:
5834:
5684:
1840:
256:
follows the principle that an extensive state of the art physicochemical, analytical and functional comparison of the molecules is complemented by comparative non-clinical and clinical data that establish equivalent efficacy and safety in a clinical "model" indication that is most sensitive to detect
92:
hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies demonstrate that the biological product is highly similar to the reference product, despite minor differences in clinically
221:
are of a complex nature (composed of a long chain of amino acids, modified amino acids, derivatized by sugar moieties, folded by complex mechanisms). These proteins are made in living cells (bacteria, yeast, animal or human cell lines). The ultimate characteristics of a drug containing a recombinant
189:
In March 2020, most protein products that were approved as drug products (including every insulin currently on the market as of
December 2019) are scheduled to open up to biosimilar and interchangeable competition in the United States. However, "chemically synthesized polypeptides" are excluded from
277:
Several PK studies, such as studies conducted by
Committee for Medicinal Products for Human Use (CHMP), have been conducted under various ranges of conditions; Antibodies from an originator's product versus antibodies from a biosimilar; combination therapy and monotherapy; various diseases, etc. on
269:
plan. It is difficult and costly to recreate biologics because the complex proteins are derived from living organisms that are genetically modified. In contrast, small molecule drugs made up of a chemically based compound can be easily replicated and are considerably less expensive to reproduce. In
248:
The typical reference product has undergone numerous changes in its manufacturing processes, and such changes in the manufacturing process (ranging from a change in the supplier of cell culture media to new purification methods or new manufacturing sites) was substantiated with appropriate data and
181:
obtained the first approval of FDA. Sandoz's Zarxio is biosimilar to Amgen's
Neupogen (filgrastim), which was originally licensed in 1991. This is the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of the Affordable
273:
Generally, once a drug is released in the market by the FDA, it has to be re-evaluated for its safety and efficacy once every six months for the first and second years. Afterward, re-evaluations are conducted yearly, and the result of the assessment should be reported to authorities such as FDA.
264:
Originally the complexity of biological molecules led to requests for substantial efficacy and safety data for a biosimilar approval. This has been progressively replaced with a greater dependence on assays, from quality through to clinical, that show assay sensitivity sufficient to detect any
289:
The US decided on a different approach, requiring the assignment of a four-letter suffix to the nonproprietary name of the original product to distinguish between innovator drugs and their biosimilars. Japan has similar requirements. The suffix approach has been criticized on the grounds of
349:: The importance of establishing registries and conducting real-world evidence studies to monitor biosimilar efficacy and safety was also emphasized. A pharmacovigilance framework specific to biosimilars and biologics was suggested to be more effective than the existing general framework.
327:: The experts suggested a mandatory discount of 30–40% on the price of the first biosimilar compared to its originator, with subsequent biosimilars receiving additional discounts. It was also recommended that biosimilar prices be revised periodically, either annually or biennially.
222:
therapeutic protein are to a large part determined by the process through which they are produced: choice of the cell type, development of the genetically modified cell for production, production process, purification process, formulation of the therapeutic protein into a drug.
635:(PPAC Act), signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a
105:). They are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and is intended to be used and for which licensure is sought for the biological product.
305:
Biosimilars available in
Australia include adalimumab, bevacizumab, enoxaparin, epoetin lambda, etanercept, filgrastim, follitropin alfa, infliximab, insulin aspart, insulin glargine, pegfilgrastim, rituximab, teriparatide, and trastuzumab.
53:
that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's
270:
order to be released to the public, biosimilars must be shown to be as close to identical to the parent innovator biologic product based on data compiled through clinical, animal, analytical studies and conformational status.
265:
significant difference in dose. However, the safe application of biologics depends on an informed and appropriate use by healthcare professionals and patients. Introduction of biosimilars also requires a specifically designed
5778:
6309:
2012:
260:
The EMA has recognized this fact, which has resulted in the establishment of the term "biosimilar" in recognition that, whilst biosimilar products are similar to the original product, they are not exactly the same.
190:
this transition, which means that a product that falls within this category won't be able to come to market as a biosimilar or interchangeable product, but will have to come to the market under a different pathway.
2049:
314:
A research article about "Maximizing the benefits of using biosimilars in Egypt" proposed a regulatory framework for biosimilars in Egypt. The article summarized the recommendations of a number of stakeholders.
2189:
6159:
2335:
7325:
112:(WHO) published its "Guidelines for the evaluation of similar biotherapeutic products (SBPs)" in 2009. The purpose of this guideline is to provide an international norm for evaluating biosimilars.
1825:
2218:
2138:
2082:
6249:
1402:
642:
In 2018, the FDA released a
Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for
624:
5766:
1518:
6069:
1471:
6301:
6099:
2000:
5979:
2038:
1937:
5919:
278:
the purpose to verify comparability in pharmacokinetics of the biosimilar with the reference medicinal product in a sufficiently sensitive and homogeneous population.
2182:
1626:
6151:
2324:
1590:
69:
type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all
7317:
1554:
7269:
7239:
7209:
7179:
7119:
7089:
7059:
7029:
6999:
6969:
6939:
6909:
6879:
6849:
6819:
6789:
6759:
6729:
6699:
6669:
6639:
6609:
6579:
6549:
6519:
6489:
6459:
6429:
6399:
6369:
6339:
6279:
6219:
6189:
6129:
6039:
5889:
5859:
4418:
7149:
5078:
5669:
1676:
5949:
4286:
1813:
632:
152:
5702:
2302:
2214:
2134:
2074:
4517:
4253:
3758:
1784:
6009:
1759:
151:
The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the
1648:
6241:
5819:
3364:
1692:
1413:
1354:
Blanchard, A., Helene D'Iorio and Robert Ford. "What you need to know to succeed: Key trends in Canada's biotech industry " Insights, Spring 2010
3725:
2112:
286:
In the
European Union, no unique identifier of a biosimilar medicine product is required, as the same rules are followed as for all biologics.
1580:
Guidelines on evaluation of monoclonal antibodies (mAbs) as similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 1004
358:
Biosimilar medicines approved in the
European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
3824:
3857:
1674:
Hearing: Assessing the Impact of a Safe and
Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007
4616:
3692:
3031:
1859:
1507:
386:
Amgevita, Amsparity, Cyltezo, Halimatoz, Hefiya, Hukyndra, Hulio, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma
5606:
5573:
5441:
5375:
5246:
4913:
4814:
4781:
4649:
4187:
4088:
3791:
3265:
2503:
2437:
93:
inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of
6061:
5639:
5507:
5177:
5111:
5045:
5012:
4979:
4847:
4550:
4022:
3626:
3496:
3397:
3331:
3298:
3163:
2998:
2800:
2767:
2569:
2404:
1482:
198:
Cloning of human genetic material and development of in vitro biological production systems has allowed the production of virtually any
5474:
5345:
5312:
5279:
5210:
5144:
4946:
4880:
4748:
4682:
4583:
4484:
4451:
4352:
4319:
4121:
4055:
3989:
3956:
3923:
3659:
3590:
3196:
3097:
2965:
2899:
2866:
2833:
2734:
2701:
2635:
2470:
5540:
5408:
4715:
4385:
4154:
3890:
3529:
3463:
3430:
3232:
3130:
2932:
2668:
2536:
2371:
2160:
6091:
4220:
3064:
2602:
294:
1925:
257:
any minor differences (if these exist) between the biosimilar and its reference monoclonal antibody also at the clinical level.
7501:
1718:
85:
5971:
5911:
5767:"Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars policy framework"
7466:
293:
A version of the four-letter suffix has been proposed to the WHO as the biological qualifier (BQ). It is not part of the
7459:
7450:
7441:
7321:
7295:
7265:
7235:
7205:
7175:
7145:
7115:
7085:
7055:
7025:
6995:
6965:
6935:
6905:
6875:
6845:
6815:
6785:
6755:
6725:
6695:
6665:
6635:
6605:
6575:
6545:
6515:
6485:
6455:
6425:
6395:
6365:
6335:
6305:
6275:
6245:
6215:
6185:
6155:
6125:
6095:
6065:
6035:
6005:
5975:
5945:
5915:
5885:
5855:
5815:
5772:
2006:
1819:
1790:
1753:
1724:
1698:
636:
334:
145:
81:
1615:
290:
compromising the INN system and delaying the marketing of biosimilars. Australia decided not to use a 4-letter suffix.
7496:
451:
Accofil, Biograstim, Filgrastim Hexal, Filgrastim ratiopharm, Grastofil, Nivestim, Ratiograstim, Tevagrastim, Zarzio
123:
in the EU in 2013. On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of
1579:
1543:
7291:
7261:
7231:
7201:
7171:
7141:
7111:
7081:
7051:
7021:
6991:
6961:
6931:
6901:
6871:
6841:
6811:
6781:
6751:
6721:
6691:
6661:
6631:
6601:
6571:
6541:
6511:
6481:
6451:
6421:
6391:
6361:
6331:
6271:
6211:
6181:
6121:
6031:
5881:
5851:
5633:
5600:
5567:
5534:
5501:
5468:
5435:
5402:
5339:
5306:
5273:
5240:
5204:
5171:
5138:
5105:
5072:
5039:
5006:
4973:
4940:
4907:
4874:
4841:
4808:
4775:
4742:
4709:
4676:
4643:
4610:
4577:
4544:
4511:
4478:
4445:
4412:
4407:
4379:
4346:
4313:
4280:
4247:
4214:
4181:
4148:
4115:
4082:
4049:
4016:
3983:
3950:
3917:
3884:
3851:
3818:
3785:
3752:
3719:
3686:
3653:
3620:
3584:
3556:
3523:
3490:
3457:
3424:
3391:
3358:
3325:
3292:
3259:
3226:
3190:
3157:
3124:
3091:
3058:
3025:
2992:
2959:
2926:
2893:
2860:
2827:
2794:
2761:
2728:
2695:
2662:
2629:
2596:
2563:
2530:
2497:
2464:
2431:
2398:
2365:
2296:
1620:
1586:
1550:
1514:
1478:
109:
77:
5067:
1649:"US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004"
115:
The EMA has granted marketing authorizations for more than 50 biosimilars since 2006. The first biosimilar of a
5661:
1673:
242:
73:, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.
5941:
4275:
206:
technology combined with recombinant DNA technology has paved the way for tailor-made and targeted medicines.
5741:
2291:
1508:
Guidelines on evaluation of similar
Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977
1796:
4506:
4242:
3747:
6001:
2183:"WHO Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products"
1744:
6302:"FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment"
1704:
253:
31:
5811:
3353:
1719:"FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting""
3714:
2104:
1652:
203:
116:
1693:"FDA page on "Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing""
7419:
7376:
5733:
3813:
1384:
646:
and transitioning insulin and human growth hormone to regulation as biologics rather than drugs.
3846:
4605:
3681:
3020:
1856:
7411:
7368:
5725:
5595:
5562:
5430:
5367:
5235:
4902:
4803:
4770:
4638:
4176:
4077:
3780:
3254:
2492:
2426:
2273:
1982:
1906:
1453:
404:
266:
171:
70:
50:
5628:
5496:
5166:
5100:
5034:
5001:
4968:
4836:
4539:
4011:
3615:
3485:
3386:
3320:
3287:
3152:
2987:
2789:
2756:
2558:
2393:
1430:
Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, et al. (April 2018).
7401:
7360:
5717:
5463:
5334:
5301:
5268:
5199:
5133:
4935:
4869:
4737:
4671:
4572:
4473:
4440:
4341:
4308:
4110:
4044:
3978:
3945:
3912:
3648:
3579:
3551:
3185:
3086:
2954:
2888:
2855:
2822:
2723:
2690:
2624:
2459:
2263:
2253:
2168:
1972:
1896:
1888:
1443:
1376:
1108:
1080:
495:
456:
102:
98:
5529:
5397:
4704:
4374:
4143:
3879:
3518:
3452:
3419:
3221:
3119:
2921:
2657:
2525:
2360:
7480:
4209:
3053:
2591:
1863:
1680:
199:
55:
7390:"Biosimilar epoetins and other "follow-on" biologics: update on the European experiences"
7389:
2001:"Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability"
241:, monoclonal antibodies and more) any other biotech company can develop and market these
2268:
2241:
2240:
Fasseeh AN, Elezbawy B, El-Fass KA, GamaI M, Seyam A, Hayek N, et al. (June 2023).
1926:"Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies"
627:
of 2009 (BPCI Act) was originally sponsored and introduced on June 26, 2007, by
Senator
6152:"FDA approves first biosimilar for the treatment of certain breast and stomach cancers"
1901:
1876:
508:
482:
238:
230:
94:
66:
58:
expires. Reference to the innovator product is an integral component of the approval.
7490:
7423:
5838:
5688:
1892:
1844:
1730:
1192:
1164:
1038:
996:
856:
814:
521:
89:
7380:
5737:
1388:
158:
The FDA has previously approved biologic products using comparability, for example,
800:
643:
573:
417:
211:
207:
62:
1448:
1431:
1977:
1960:
1367:
Nick, C (2012). "The US Biosimilars Act: Challenges Facing Regulatory Approval".
399:
Abevmy, Alymsys, Aybintio, Equidacent, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev
1290:
1276:
1262:
1248:
1206:
1178:
1150:
1094:
954:
940:
912:
898:
884:
772:
758:
628:
599:
586:
534:
391:
234:
2258:
1877:"Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?"
1432:"Maintaining consistent quality and clinical performance of biopharmaceuticals"
2325:"EU Approved biosimilars by molecule [data arranged from EMA website]"
1304:
1234:
1220:
1136:
1122:
1052:
1024:
1010:
982:
926:
842:
828:
786:
744:
730:
716:
702:
688:
674:
560:
469:
443:
430:
378:
167:
163:
124:
120:
529:
Cegfila, Fulphila, Grasustek, Pelgraz, Pelmeg, Udenyca, Stimufend, Ziextenzo
7455:
7446:
7437:
7318:"FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases"
1332:
1318:
1066:
968:
870:
547:
159:
7415:
7372:
5729:
2277:
2075:"Australian Government Announces Decision on Biosimilar Naming Conventions"
1986:
1910:
1457:
17:
5721:
218:
7364:
6242:"FDA approves first epoetin alfa biosimilar for the treatment of anemia"
1961:"Biosimilar monoclonal antibodies: a science-based regulatory challenge"
5703:"Biosimilars: the need, the challenge, the future: the FDA perspective"
1814:"Statement on low-cost biosimilar and interchangeable protein products"
1403:"Biosimilars in the EU: Information guide for healthcare professionals"
1380:
226:
7406:
7351:
Udpa N, Million RP (January 2016). "Monoclonal antibody biosimilars".
183:
178:
128:
2039:"The International Debate on Generic Medicines of Biological Origin"
225:
After the expiry of the patent of approved recombinant drugs (e.g.,
5806:
5804:
5802:
5800:
5798:
5796:
555:
Blitzima, Ritemvia, Rituzena, Rixathon, Riximyo, Ruxience, Truxima
1472:
Guidelines on evaluation of similar Biotherapeutic Products (SBPs)
5837:
This article incorporates text from this source, which is in the
5687:
This article incorporates text from this source, which is in the
1843:
This article incorporates text from this source, which is in the
202:
based biological substance for eventual development of a drug.
1745:"FDA Response to three Citizen Petitions against biosimilars"
1785:"FDA page on "FDA approves first biosimilar product Zarxio""
6092:"FDA approves first biosimilar for the treatment of cancer"
1544:
WHO Questions and Answers: Similar Biotherapeutic Products
607:
Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac
425:
Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo
5701:
Epstein MS, Ehrenpreis ED, Kulkarni PM (December 2014).
2215:"Which biosimilar medicines are available in Australia?"
2135:"Which biosimilar medicines are available in Australia?"
2242:"Maximizing the benefits of using biosimilars in Egypt"
1857:
EMEA guideline on similar biological medicinal products
490:
Fiasp, Insulin aspart Sanofi, Kirsty, NovoMix, Ryzodeg
6272:"Drug Approval Package: Retacrit (epoetin alfa-epbx )"
155:
signed into law by President Obama on March 23, 2010.
7464:
6542:"Drug Approval Package: Trazimera (trastuzumab-qyyp)"
6512:"Drug Approval Package: Ontruzant (trastuzumab-dttb)"
4573:"Cegfila (previously Pegfilgrastim Mundipharma) EPAR"
1410:
European Medicines Agency and the European Commission
6032:"Drug Approval Package: Renflexis (infliximab-abda)"
6362:"Drug Approval Package: Nivestym (filgrastim-aafi)"
6002:"Drug Approval Package: Amjevita (adalimumab-atto)"
6182:"Drug Approval Package: Ogivri (Trastuzumab-dkst)"
5230:
5228:
6452:"Drug Approval Package: Truxima (rituximab-abbs)"
6122:"Drug Approval Package: Mvasi (bevacizumab-awwb)"
5942:"Drug Approval Package: Erelzi (etanercept-szzs)"
1362:
1360:
252:The current concept of development of biosimilar
6212:"Drug Approval Package: Ixifi (infliximab-qbtx)"
3610:
3608:
1808:
1806:
5972:"FDA approves Amjevita, a biosimilar to Humira"
319:Key Findings and Recommendations of the article
80:(EMA) of the European Union, the United States
3216:
3214:
625:Biologics Price Competition and Innovation Act
127:called filgrastim-sndz (trade name Zarxio) by
5912:"FDA approves Erelzi, a biosimilar to Enbrel"
2246:Journal of Pharmaceutical Policy and Practice
333:: A significant emphasis was placed on using
119:to be approved worldwide was a biosimilar of
8:
5882:"Inflectra (infliximab-dyyb) for Injection"
7447:Biosimilar Regulatory Review and Approval
7232:"Drug Approval Package: Yuflyma injection"
2292:"Biosimilar medicines can be interchanged"
633:Patient Protection and Affordable Care Act
214:therapies are emerging as new approaches.
153:Patient Protection and Affordable Care Act
7405:
2267:
2257:
1976:
1900:
1447:
631:(D-MA). It was formally passed under the
5710:The American Journal of Gastroenterology
1881:British Journal of Clinical Pharmacology
653:
360:
7471:
7122:from the original on September 29, 2022
6282:from the original on September 27, 2021
4883:from the original on September 10, 2021
4850:from the original on September 10, 2021
4289:from the original on September 15, 2021
4190:from the original on September 22, 2023
3992:from the original on September 23, 2020
2341:from the original on September 19, 2020
2305:from the original on September 20, 2022
1347:
7328:from the original on November 13, 2023
7272:from the original on November 26, 2023
7212:from the original on February 10, 2023
7092:from the original on September 3, 2022
6702:from the original on December 18, 2019
6672:from the original on December 18, 2019
6642:from the original on December 18, 2019
6612:from the original on December 18, 2019
6582:from the original on December 18, 2019
6552:from the original on December 18, 2019
6522:from the original on December 18, 2019
6492:from the original on December 18, 2019
6462:from the original on December 18, 2019
6432:from the original on December 18, 2019
6402:from the original on December 18, 2019
6372:from the original on December 20, 2019
6222:from the original on December 18, 2019
6162:from the original on December 15, 2019
6132:from the original on February 23, 2023
6072:from the original on February 18, 2020
6042:from the original on December 18, 2019
5982:from the original on November 19, 2019
5862:from the original on December 20, 2019
5378:from the original on December 18, 2021
5213:from the original on September 9, 2021
5180:from the original on September 9, 2021
5147:from the original on September 9, 2021
5114:from the original on September 9, 2021
5081:from the original on September 9, 2021
5048:from the original on September 9, 2021
5015:from the original on September 9, 2021
4982:from the original on September 9, 2021
4685:from the original on December 30, 2019
4520:from the original on February 24, 2020
4487:from the original on February 24, 2020
4454:from the original on February 15, 2022
4157:from the original on December 30, 2019
4124:from the original on December 29, 2019
3794:from the original on November 12, 2020
3728:from the original on December 30, 2019
3629:from the original on December 20, 2019
3532:from the original on December 30, 2019
3499:from the original on December 30, 2019
3466:from the original on November 12, 2020
3400:from the original on December 30, 2019
3367:from the original on December 30, 2019
3334:from the original on December 30, 2019
3268:from the original on December 30, 2019
3199:from the original on December 30, 2019
3067:from the original on December 30, 2019
3001:from the original on December 29, 2020
2836:from the original on February 18, 2020
2737:from the original on December 30, 2019
2671:from the original on December 30, 2019
2638:from the original on November 16, 2019
2506:from the original on December 30, 2019
2440:from the original on February 18, 2020
2407:from the original on December 30, 2019
2374:from the original on February 18, 2020
2221:from the original on December 30, 2021
2141:from the original on December 30, 2021
2115:from the original on December 30, 2021
2109:Therapeutic Goods Administration (TGA)
2085:from the original on December 30, 2021
2015:from the original on September 6, 2019
1828:from the original on December 18, 2019
7152:from the original on January 26, 2023
6942:from the original on January 25, 2023
6852:from the original on November 6, 2021
6822:from the original on January 25, 2021
6792:from the original on November 1, 2020
6102:from the original on November 5, 2021
6062:"Cyltezo: FDA Approved Drug Products"
5952:from the original on December 5, 2022
5510:from the original on October 31, 2020
5477:from the original on November 8, 2020
4091:from the original on October 16, 2019
4058:from the original on October 16, 2019
4025:from the original on October 22, 2020
3959:from the original on October 28, 2020
3893:from the original on October 15, 2019
3860:from the original on October 16, 2019
3761:from the original on January 21, 2021
3695:from the original on October 22, 2020
3433:from the original on October 22, 2020
3235:from the original on October 29, 2020
3166:from the original on January 28, 2023
3100:from the original on November 5, 2021
3034:from the original on October 13, 2020
2539:from the original on October 15, 2019
2301:(Press release). September 19, 2022.
2195:from the original on October 31, 2017
2032:
2030:
1940:from the original on January 19, 2021
76:Drug-related authorities such as the
7:
7456:Interchangeable Biological Products
7242:from the original on August 25, 2023
7182:from the original on August 25, 2023
6882:from the original on August 28, 2021
6762:from the original on October 4, 2020
6252:from the original on August 28, 2021
6012:from the original on October 4, 2020
5922:from the original on August 28, 2021
5822:from the original on August 28, 2021
5777:(Press release). December 11, 2018.
5672:from the original on August 28, 2021
5411:from the original on October 5, 2023
5348:from the original on August 14, 2019
4916:from the original on October 6, 2022
4355:from the original on August 28, 2021
4223:from the original on August 28, 2021
3827:from the original on August 14, 2020
3133:from the original on October 8, 2021
2968:from the original on October 8, 2021
2935:from the original on August 28, 2021
2869:from the original on August 28, 2021
1965:Expert Opinion on Biological Therapy
1436:Expert Opinion on Biological Therapy
477:Flixabi, Inflectra, Remsima, Zessly
362:European Union approved biosimilars
347:Post-Marketing and Pharmacovigilance
6192:from the original on March 22, 2023
5576:from the original on August 4, 2020
5543:from the original on March 24, 2020
4949:from the original on March 13, 2023
4784:from the original on April 21, 2022
4388:from the original on August 4, 2020
4322:from the original on April 13, 2020
3662:from the original on March 23, 2020
3301:from the original on March 23, 2020
2902:from the original on March 18, 2020
2770:from the original on April 24, 2022
2704:from the original on March 24, 2020
2605:from the original on March 24, 2020
2572:from the original on April 24, 2022
2473:from the original on August 6, 2020
1629:from the original on March 29, 2020
1596:from the original on April 14, 2021
1560:from the original on April 21, 2019
438:Benepali, Erelzi, Lifmior, Nepexto
7292:"Drug Approval Package: Tofidence"
7142:"Drug Approval Package: Stimufend"
6962:"Drug Approval Package: Rezvoglar"
6732:from the original on June 11, 2020
6722:"Drug Approval Package: Ziextenzo"
6342:from the original on June 11, 2020
6312:from the original on June 11, 2020
5642:from the original on July 28, 2020
5609:from the original on July 28, 2020
5444:from the original on July 28, 2020
5282:from the original on June 27, 2020
5249:from the original on July 27, 2020
4817:from the original on June 11, 2020
4751:from the original on June 11, 2020
4718:from the original on June 11, 2020
4652:from the original on June 11, 2020
4619:from the original on June 11, 2020
4586:from the original on June 11, 2020
4553:from the original on June 11, 2020
4421:from the original on April 2, 2022
4256:from the original on July 17, 2020
2803:from the original on June 25, 2019
2055:from the original on March 6, 2021
25:
7172:"Drug Approval Package: Vegzelma"
7082:"Drug Approval Package: Fylnetra"
7062:from the original on May 27, 2022
7032:from the original on May 27, 2022
7002:from the original on May 27, 2022
6972:from the original on May 27, 2022
6912:from the original on May 27, 2022
6812:"Drug Approval Package: Nyvepria"
6752:"Drug Approval Package: Abrilada"
6662:"Drug Approval Package: Ruxience"
6602:"Drug Approval Package: Kanjinti"
6332:"Drug Approval Package: Fulphila"
5892:from the original on May 20, 2022
5666:U.S. Food and Drug Administration
3926:from the original on July 1, 2020
3593:from the original on June 4, 2020
2105:"Biosimilar medicines regulation"
1765:from the original on May 31, 2017
1524:from the original on May 30, 2015
295:international nonproprietary name
166:was also to a reference product,
7474:
7112:"Drug Approval Package: Cimerli"
7052:"Drug Approval Package: Alymsys"
7022:"Drug Approval Package: Releuko"
6992:"Drug Approval Package: Yusimry"
6932:"Drug Approval Package: Byooviz"
6902:"Drug Approval Package: Semglee"
6692:"Drug Approval Package: Hadlima"
6632:"Drug Approval Package: Zirabev"
6572:"Drug Approval Package: Eticovo"
6482:"Drug Approval Package: Herzuma"
6422:"Drug Approval Package: Udenyca"
6392:"Drug Approval Package: Hyrimoz"
5832:
5781:from the original on May 8, 2019
5682:
5315:from the original on May 1, 2022
1893:10.1111/j.1365-2125.2012.04323.x
1838:
1616:"Biosimilar medicines: Overview"
7438:Overview of Biosimilar Products
7262:"Drug Approval Package: Tyruko"
7202:"Drug Approval Package: Idacio"
6872:"Drug Approval Package: Riabni"
6782:"Drug Approval Package: Avsola"
1105:insulin glargine-aglr/Rezvoglar
657:Date of Biosimilar FDA Approval
86:Health Products and Food Branch
7394:American Journal of Hematology
7353:Nature Reviews. Drug Discovery
6842:"Drug Approval Package: Hulio"
27:Variant of a biopharmaceutical
1:
5812:"Biosimilar Drug Information"
1959:Declerck PJ (February 2013).
1449:10.1080/14712598.2018.1421169
1077:insulin glargine-yfgn/Semglee
7460:Food and Drug Administration
7451:Food and Drug Administration
7442:Food and Drug Administration
7322:Food and Drug Administration
7296:Food and Drug Administration
7266:Food and Drug Administration
7236:Food and Drug Administration
7206:Food and Drug Administration
7176:Food and Drug Administration
7146:Food and Drug Administration
7116:Food and Drug Administration
7086:Food and Drug Administration
7056:Food and Drug Administration
7026:Food and Drug Administration
6996:Food and Drug Administration
6966:Food and Drug Administration
6936:Food and Drug Administration
6906:Food and Drug Administration
6876:Food and Drug Administration
6846:Food and Drug Administration
6816:Food and Drug Administration
6786:Food and Drug Administration
6756:Food and Drug Administration
6726:Food and Drug Administration
6696:Food and Drug Administration
6666:Food and Drug Administration
6636:Food and Drug Administration
6606:Food and Drug Administration
6576:Food and Drug Administration
6546:Food and Drug Administration
6516:Food and Drug Administration
6486:Food and Drug Administration
6456:Food and Drug Administration
6426:Food and Drug Administration
6396:Food and Drug Administration
6366:Food and Drug Administration
6336:Food and Drug Administration
6306:Food and Drug Administration
6276:Food and Drug Administration
6246:Food and Drug Administration
6216:Food and Drug Administration
6186:Food and Drug Administration
6156:Food and Drug Administration
6126:Food and Drug Administration
6096:Food and Drug Administration
6066:Food and Drug Administration
6036:Food and Drug Administration
6006:Food and Drug Administration
5976:Food and Drug Administration
5946:Food and Drug Administration
5916:Food and Drug Administration
5886:Food and Drug Administration
5856:Food and Drug Administration
5816:Food and Drug Administration
5773:Food and Drug Administration
4507:"Insulin lispro Sanofi EPAR"
4243:"Insulin aspart Sanofi EPAR"
3748:"Filgrastim ratiopharm EPAR"
2007:Food and Drug Administration
1978:10.1517/14712598.2012.758710
1820:Food and Drug Administration
1791:Food and Drug Administration
1754:Food and Drug Administration
1725:Food and Drug Administration
1699:Food and Drug Administration
1189:pegfilgrastim-fpgk/Stimufend
993:pegfilgrastim-bmez/Ziextenzo
637:Food and Drug Administration
542:Byooviz, Ranivisio, Ximluci
335:Health Technology Assessment
146:Food and Drug Administration
82:Food and Drug Administration
7388:Jelkmann W (October 2010).
2037:Velásquez G (August 2018).
1679:September 22, 2007, at the
1481:(WHO). 2009. Archived from
1161:pegfilgrastim-pbbk/Fylnetra
1035:pegfilgrastim-apgf/Nyvepria
811:pegfilgrastim-jmdb/Fulphila
245:(thus called biosimilars).
186:is biosimilar to Neupogen.
170:, originally approved as a
162:in May 2006, but this like
7518:
7178:(FDA). December 13, 2022.
7148:(FDA). November 16, 2022.
6908:(FDA). September 2, 2021.
6728:(FDA). December 27, 2019.
6698:(FDA). September 5, 2019.
6458:(FDA). February 25, 2019.
6368:(FDA). February 21, 2019.
6278:(FDA). December 13, 2018.
6218:(FDA). November 29, 2018.
6188:(FDA). November 29, 2018.
6038:(FDA). December 10, 2018.
5852:"Zarxio (filgrastim-sndz)"
2259:10.1186/s40545-023-00581-w
2079:The Center For Biosimilars
1875:Warren JB (January 2013).
1259:tocilizumab-bavi/Tofidence
909:trastuzumab-qyyp/Trazimera
895:trastuzumab-dttb/Ontruzant
853:pegfilgrastim-cbqv/Udenyca
797:epoetin alfa-epbx/Retacrit
144:In the United States, the
29:
7324:(FDA). October 31, 2023.
7268:(FDA). October 11, 2023.
7208:(FDA). February 9, 2023.
6998:(FDA). January 18, 2021.
6968:(FDA). January 28, 2022.
6878:(FDA). January 26, 2021.
6788:(FDA). January 30, 2020.
6758:(FDA). January 28, 2020.
6488:(FDA). February 7, 2019.
6338:(FDA). October 26, 2018.
6128:(FDA). October 10, 2018.
6008:(FDA). November 9, 2016.
5948:(FDA). October 25, 2016.
5634:European Medicines Agency
5601:European Medicines Agency
5568:European Medicines Agency
5535:European Medicines Agency
5502:European Medicines Agency
5469:European Medicines Agency
5436:European Medicines Agency
5403:European Medicines Agency
5372:European Medicines Agency
5340:European Medicines Agency
5307:European Medicines Agency
5274:European Medicines Agency
5241:European Medicines Agency
5205:European Medicines Agency
5172:European Medicines Agency
5139:European Medicines Agency
5106:European Medicines Agency
5073:European Medicines Agency
5040:European Medicines Agency
5007:European Medicines Agency
4974:European Medicines Agency
4941:European Medicines Agency
4908:European Medicines Agency
4875:European Medicines Agency
4842:European Medicines Agency
4809:European Medicines Agency
4776:European Medicines Agency
4743:European Medicines Agency
4710:European Medicines Agency
4677:European Medicines Agency
4644:European Medicines Agency
4611:European Medicines Agency
4578:European Medicines Agency
4545:European Medicines Agency
4512:European Medicines Agency
4479:European Medicines Agency
4446:European Medicines Agency
4413:European Medicines Agency
4380:European Medicines Agency
4347:European Medicines Agency
4314:European Medicines Agency
4281:European Medicines Agency
4248:European Medicines Agency
4215:European Medicines Agency
4182:European Medicines Agency
4149:European Medicines Agency
4116:European Medicines Agency
4083:European Medicines Agency
4050:European Medicines Agency
4017:European Medicines Agency
3984:European Medicines Agency
3951:European Medicines Agency
3918:European Medicines Agency
3885:European Medicines Agency
3852:European Medicines Agency
3819:European Medicines Agency
3786:European Medicines Agency
3753:European Medicines Agency
3720:European Medicines Agency
3687:European Medicines Agency
3654:European Medicines Agency
3621:European Medicines Agency
3585:European Medicines Agency
3557:European Medicines Agency
3524:European Medicines Agency
3491:European Medicines Agency
3458:European Medicines Agency
3425:European Medicines Agency
3392:European Medicines Agency
3359:European Medicines Agency
3354:"Epoetin Alfa Hexal EPAR"
3326:European Medicines Agency
3293:European Medicines Agency
3260:European Medicines Agency
3227:European Medicines Agency
3191:European Medicines Agency
3158:European Medicines Agency
3125:European Medicines Agency
3092:European Medicines Agency
3059:European Medicines Agency
3026:European Medicines Agency
2993:European Medicines Agency
2960:European Medicines Agency
2927:European Medicines Agency
2894:European Medicines Agency
2861:European Medicines Agency
2828:European Medicines Agency
2795:European Medicines Agency
2762:European Medicines Agency
2729:European Medicines Agency
2696:European Medicines Agency
2663:European Medicines Agency
2630:European Medicines Agency
2597:European Medicines Agency
2564:European Medicines Agency
2531:European Medicines Agency
2498:European Medicines Agency
2465:European Medicines Agency
2432:European Medicines Agency
2399:European Medicines Agency
2366:European Medicines Agency
2297:European Medicines Agency
2046:South Centre Policy Brief
1621:European Medicines Agency
1587:World Health Organization
1551:World Health Organization
1515:World Health Organization
1479:World Health Organization
1203:bevacizumab-adcd/Vegzelma
937:trastuzumab-anns/Kanjinti
727:infliximab-abda/Renflexis
685:infliximab-dyyb/Inflectra
249:was approved by the EMA.
110:World Health Organization
78:European Medicines Agency
47:subsequent entry biologic
7238:(FDA). August 11, 2023.
7118:(FDA). August 23, 2022.
6938:(FDA). October 1, 2021.
6848:(FDA). October 2, 2020.
6818:(FDA). August 11, 2020.
6638:(FDA). August 14, 2019.
1930:BioProcess International
1301:adalimumab-ryvk/Simlandi
1273:ustekinumab-auub/Wezlana
1175:ranibizumab-eqrn/Cimerli
1147:bevacizumab-maly/Alymsys
1091:ranibizumab-nuna/Byooviz
1007:adalimumab-afzb/Abrilada
951:bevacizumab-bvzr/Zirabev
881:trastuzumab-pkrb/Herzuma
825:filgrastim-aafi/Nivestym
713:adalimumab-atto/Amjevita
217:Recombinant therapeutic
174:under the FD&C Act.
51:biologic medical product
7298:(FDA). November 7, 2023
7028:(FDA). April 11, 2022.
6668:(FDA). August 9, 2019.
6398:(FDA). March 21, 2019.
5858:(FDA). April 20, 2015.
3715:"Filgrastim Hexal EPAR"
1924:Wang X (June 1, 2014).
1315:denosumab-bbdz/Jubbonti
1287:bevacizumab-tnjn/Avzivi
1245:natalizumab-sztn/Tyruko
1231:adalimumab-aaty/Yuflyma
1133:filgrastim-ayow/Releuko
1119:adalimumab-aqvh/Yusimry
979:adalimumab-bwwd/Hadlima
965:rituximab-pvvr/Ruxience
923:etanercept-ykro/Eticovo
839:adalimumab-adaz/Hyrimoz
769:trastuzumab-dkst/Ogivri
741:adalimumab-adbm/Cyltezo
650:US approved biosimilars
7502:Life sciences industry
7320:(Press release). U.S.
7088:(FDA). July 15, 2022.
6608:(FDA). July 18, 2019.
6578:(FDA). June 18, 2019.
6518:(FDA). March 5, 2019.
6428:(FDA). March 5, 2019.
6304:(Press release). U.S.
6244:(Press release). U.S.
6154:(Press release). U.S.
6094:(Press release). U.S.
5974:(Press release). U.S.
5914:(Press release). U.S.
5888:(FDA). June 27, 2016.
4945:. September 14, 2022.
4813:. September 24, 2018.
4714:. September 24, 2018.
4615:. September 24, 2018.
3757:. September 17, 2018.
3691:. September 17, 2018.
2766:. September 14, 2021.
2568:. September 14, 2021.
2161:"Biological Qualifier"
1862:June 30, 2007, at the
1625:. September 17, 2018.
1412:. 2017. Archived from
1217:adalimumab-aacf/Idacio
1021:infliximab-axxq/Avsola
867:rituximab-abbs/Truxima
755:bevacizumab-awwb/Mvasi
699:etanercept-szzs/Erelzi
671:filgrastim-sndz/Zarxio
516:Insulin lispro Sanofi
7058:(FDA). May 11, 2022.
6548:(FDA). May 17, 2019.
3195:. December 11, 2018.
2931:. February 24, 2021.
2332:Biosimilars Nederland
1824:. December 17, 2019.
1488:on September 29, 2021
1063:rituximab-arrx/Riabni
1049:adalimumab-fkjp/Hulio
783:infliximab-qbtx/Ixifi
373:Biosimilar medicines
254:monoclonal antibodies
32:Biosimilars (journal)
30:For the journal, see
5722:10.1038/ajg.2014.151
5374:. January 16, 2009.
5176:. January 29, 2020.
4780:. January 24, 2022.
4582:. October 16, 2019.
4285:. December 9, 2020.
3922:. October 20, 1995.
3129:. January 25, 2021.
3096:. November 9, 2020.
2964:. January 25, 2021.
2865:. December 9, 2020.
2733:. January 29, 2019.
2667:. January 29, 2019.
2436:. December 9, 2019.
2081:. January 31, 2018.
1655:on December 28, 2016
1419:on October 15, 2019.
1329:denosumab-bbdz/Wyost
7365:10.1038/nrd.2015.12
3814:"Ratiograstim EPAR"
1733:on October 7, 2010.
503:Abasaglar, Semglee
363:
204:Monoclonal antibody
117:monoclonal antibody
65:of the more common
7497:Biopharmaceuticals
5747:on October 6, 2016
4648:. April 24, 2019.
4252:. April 28, 2020.
3847:"Tevagrastim EPAR"
3589:. March 24, 2020.
2171:on March 28, 2015.
1381:10.1007/bf03262388
660:Biosimilar Product
412:Inhixa, Thorinane
361:
177:On March 6, 2015,
135:Approval processes
71:biopharmaceuticals
43:follow-on biologic
7407:10.1002/ajh.21805
5668:. July 27, 2021.
4912:. June 20, 2022.
4879:. June 23, 2021.
3682:"Biograstim EPAR"
3162:. June 20, 2022.
3030:. July 20, 2020.
3021:"Equidacent EPAR"
2111:. April 4, 2018.
1799:on March 7, 2015.
1339:
1338:
663:Original Product
611:
610:
581:Movymia, Terrosa
464:Bemfola, Ovaleap
405:Enoxaparin sodium
370:Reference product
267:pharmacovigilance
16:(Redirected from
7509:
7479:
7478:
7477:
7470:
7427:
7409:
7384:
7338:
7337:
7335:
7333:
7314:
7308:
7307:
7305:
7303:
7288:
7282:
7281:
7279:
7277:
7258:
7252:
7251:
7249:
7247:
7228:
7222:
7221:
7219:
7217:
7198:
7192:
7191:
7189:
7187:
7168:
7162:
7161:
7159:
7157:
7138:
7132:
7131:
7129:
7127:
7108:
7102:
7101:
7099:
7097:
7078:
7072:
7071:
7069:
7067:
7048:
7042:
7041:
7039:
7037:
7018:
7012:
7011:
7009:
7007:
6988:
6982:
6981:
6979:
6977:
6958:
6952:
6951:
6949:
6947:
6928:
6922:
6921:
6919:
6917:
6898:
6892:
6891:
6889:
6887:
6868:
6862:
6861:
6859:
6857:
6838:
6832:
6831:
6829:
6827:
6808:
6802:
6801:
6799:
6797:
6778:
6772:
6771:
6769:
6767:
6748:
6742:
6741:
6739:
6737:
6718:
6712:
6711:
6709:
6707:
6688:
6682:
6681:
6679:
6677:
6658:
6652:
6651:
6649:
6647:
6628:
6622:
6621:
6619:
6617:
6598:
6592:
6591:
6589:
6587:
6568:
6562:
6561:
6559:
6557:
6538:
6532:
6531:
6529:
6527:
6508:
6502:
6501:
6499:
6497:
6478:
6472:
6471:
6469:
6467:
6448:
6442:
6441:
6439:
6437:
6418:
6412:
6411:
6409:
6407:
6388:
6382:
6381:
6379:
6377:
6358:
6352:
6351:
6349:
6347:
6328:
6322:
6321:
6319:
6317:
6298:
6292:
6291:
6289:
6287:
6268:
6262:
6261:
6259:
6257:
6238:
6232:
6231:
6229:
6227:
6208:
6202:
6201:
6199:
6197:
6178:
6172:
6171:
6169:
6167:
6148:
6142:
6141:
6139:
6137:
6118:
6112:
6111:
6109:
6107:
6088:
6082:
6081:
6079:
6077:
6058:
6052:
6051:
6049:
6047:
6028:
6022:
6021:
6019:
6017:
5998:
5992:
5991:
5989:
5987:
5968:
5962:
5961:
5959:
5957:
5938:
5932:
5931:
5929:
5927:
5908:
5902:
5901:
5899:
5897:
5878:
5872:
5871:
5869:
5867:
5848:
5842:
5836:
5835:
5831:
5829:
5827:
5808:
5791:
5790:
5788:
5786:
5763:
5757:
5756:
5754:
5752:
5746:
5740:. Archived from
5707:
5698:
5692:
5686:
5685:
5681:
5679:
5677:
5658:
5652:
5651:
5649:
5647:
5638:. May 26, 2020.
5625:
5619:
5618:
5616:
5614:
5596:"Trazimera EPAR"
5592:
5586:
5585:
5583:
5581:
5563:"Ontruzant EPAR"
5559:
5553:
5552:
5550:
5548:
5526:
5520:
5519:
5517:
5515:
5493:
5487:
5486:
5484:
5482:
5460:
5454:
5453:
5451:
5449:
5431:"Herceptin EPAR"
5427:
5421:
5420:
5418:
5416:
5394:
5388:
5387:
5385:
5383:
5368:"RoActemra EPAR"
5364:
5358:
5357:
5355:
5353:
5331:
5325:
5324:
5322:
5320:
5298:
5292:
5291:
5289:
5287:
5265:
5259:
5258:
5256:
5254:
5236:"Omnitrope EPAR"
5232:
5223:
5222:
5220:
5218:
5196:
5190:
5189:
5187:
5185:
5163:
5157:
5156:
5154:
5152:
5130:
5124:
5123:
5121:
5119:
5097:
5091:
5090:
5088:
5086:
5064:
5058:
5057:
5055:
5053:
5031:
5025:
5024:
5022:
5020:
4998:
4992:
4991:
4989:
4987:
4965:
4959:
4958:
4956:
4954:
4932:
4926:
4925:
4923:
4921:
4903:"Ranivisio EPAR"
4899:
4893:
4892:
4890:
4888:
4866:
4860:
4859:
4857:
4855:
4833:
4827:
4826:
4824:
4822:
4804:"Ziextenzo EPAR"
4800:
4794:
4793:
4791:
4789:
4771:"Stimufend EPAR"
4767:
4761:
4760:
4758:
4756:
4734:
4728:
4727:
4725:
4723:
4701:
4695:
4694:
4692:
4690:
4668:
4662:
4661:
4659:
4657:
4639:"Grasustek EPAR"
4635:
4629:
4628:
4626:
4624:
4602:
4596:
4595:
4593:
4591:
4569:
4563:
4562:
4560:
4558:
4536:
4530:
4529:
4527:
4525:
4503:
4497:
4496:
4494:
4492:
4470:
4464:
4463:
4461:
4459:
4437:
4431:
4430:
4428:
4426:
4408:"Abasaglar EPAR"
4404:
4398:
4397:
4395:
4393:
4371:
4365:
4364:
4362:
4360:
4338:
4332:
4331:
4329:
4327:
4305:
4299:
4298:
4296:
4294:
4272:
4266:
4265:
4263:
4261:
4239:
4233:
4232:
4230:
4228:
4206:
4200:
4199:
4197:
4195:
4177:"NovoRapid EPAR"
4173:
4167:
4166:
4164:
4162:
4140:
4134:
4133:
4131:
4129:
4107:
4101:
4100:
4098:
4096:
4078:"Inflectra EPAR"
4074:
4068:
4067:
4065:
4063:
4041:
4035:
4034:
4032:
4030:
4008:
4002:
4001:
3999:
3997:
3975:
3969:
3968:
3966:
3964:
3942:
3936:
3935:
3933:
3931:
3909:
3903:
3902:
3900:
3898:
3876:
3870:
3869:
3867:
3865:
3843:
3837:
3836:
3834:
3832:
3810:
3804:
3803:
3801:
3799:
3781:"Grastofil EPAR"
3777:
3771:
3770:
3768:
3766:
3744:
3738:
3737:
3735:
3733:
3711:
3705:
3704:
3702:
3700:
3678:
3672:
3671:
3669:
3667:
3645:
3639:
3638:
3636:
3634:
3612:
3603:
3602:
3600:
3598:
3576:
3570:
3569:
3567:
3565:
3548:
3542:
3541:
3539:
3537:
3515:
3509:
3508:
3506:
3504:
3482:
3476:
3475:
3473:
3471:
3449:
3443:
3442:
3440:
3438:
3416:
3410:
3409:
3407:
3405:
3383:
3377:
3376:
3374:
3372:
3350:
3344:
3343:
3341:
3339:
3317:
3311:
3310:
3308:
3306:
3284:
3278:
3277:
3275:
3273:
3255:"Thorinane EPAR"
3251:
3245:
3244:
3242:
3240:
3218:
3209:
3208:
3206:
3204:
3182:
3176:
3175:
3173:
3171:
3149:
3143:
3142:
3140:
3138:
3116:
3110:
3109:
3107:
3105:
3083:
3077:
3076:
3074:
3072:
3050:
3044:
3043:
3041:
3039:
3017:
3011:
3010:
3008:
3006:
2997:. May 26, 2020.
2984:
2978:
2977:
2975:
2973:
2951:
2945:
2944:
2942:
2940:
2918:
2912:
2911:
2909:
2907:
2885:
2879:
2878:
2876:
2874:
2852:
2846:
2845:
2843:
2841:
2819:
2813:
2812:
2810:
2808:
2786:
2780:
2779:
2777:
2775:
2753:
2747:
2746:
2744:
2742:
2720:
2714:
2713:
2711:
2709:
2687:
2681:
2680:
2678:
2676:
2654:
2648:
2647:
2645:
2643:
2621:
2615:
2614:
2612:
2610:
2588:
2582:
2581:
2579:
2577:
2555:
2549:
2548:
2546:
2544:
2522:
2516:
2515:
2513:
2511:
2493:"Halimatoz EPAR"
2489:
2483:
2482:
2480:
2478:
2456:
2450:
2449:
2447:
2445:
2427:"Amsparity EPAR"
2423:
2417:
2416:
2414:
2412:
2390:
2384:
2383:
2381:
2379:
2357:
2351:
2350:
2348:
2346:
2340:
2329:
2321:
2315:
2314:
2312:
2310:
2288:
2282:
2281:
2271:
2261:
2237:
2231:
2230:
2228:
2226:
2211:
2205:
2204:
2202:
2200:
2194:
2187:
2179:
2173:
2172:
2167:. Archived from
2157:
2151:
2150:
2148:
2146:
2131:
2125:
2124:
2122:
2120:
2101:
2095:
2094:
2092:
2090:
2071:
2065:
2064:
2062:
2060:
2054:
2043:
2034:
2025:
2024:
2022:
2020:
1997:
1991:
1990:
1980:
1956:
1950:
1949:
1947:
1945:
1921:
1915:
1914:
1904:
1872:
1866:
1854:
1848:
1842:
1841:
1837:
1835:
1833:
1810:
1801:
1800:
1795:. Archived from
1781:
1775:
1774:
1772:
1770:
1764:
1749:
1741:
1735:
1734:
1729:. Archived from
1715:
1709:
1708:
1707:on July 9, 2009.
1703:. Archived from
1689:
1683:
1671:
1665:
1664:
1662:
1660:
1651:. Archived from
1645:
1639:
1638:
1636:
1634:
1612:
1606:
1605:
1603:
1601:
1595:
1584:
1576:
1570:
1569:
1567:
1565:
1559:
1548:
1540:
1534:
1533:
1531:
1529:
1523:
1512:
1504:
1498:
1497:
1495:
1493:
1487:
1476:
1468:
1462:
1461:
1451:
1427:
1421:
1420:
1418:
1407:
1399:
1393:
1392:
1364:
1355:
1352:
1109:insulin glargine
1081:insulin glargine
654:
496:Insulin glargine
457:Follitropin alfa
367:Active substance
364:
103:pharmacodynamics
99:pharmacokinetics
21:
7517:
7516:
7512:
7511:
7510:
7508:
7507:
7506:
7487:
7486:
7485:
7475:
7473:
7465:
7434:
7387:
7350:
7347:
7345:Further reading
7342:
7341:
7331:
7329:
7316:
7315:
7311:
7301:
7299:
7290:
7289:
7285:
7275:
7273:
7260:
7259:
7255:
7245:
7243:
7230:
7229:
7225:
7215:
7213:
7200:
7199:
7195:
7185:
7183:
7170:
7169:
7165:
7155:
7153:
7140:
7139:
7135:
7125:
7123:
7110:
7109:
7105:
7095:
7093:
7080:
7079:
7075:
7065:
7063:
7050:
7049:
7045:
7035:
7033:
7020:
7019:
7015:
7005:
7003:
6990:
6989:
6985:
6975:
6973:
6960:
6959:
6955:
6945:
6943:
6930:
6929:
6925:
6915:
6913:
6900:
6899:
6895:
6885:
6883:
6870:
6869:
6865:
6855:
6853:
6840:
6839:
6835:
6825:
6823:
6810:
6809:
6805:
6795:
6793:
6780:
6779:
6775:
6765:
6763:
6750:
6749:
6745:
6735:
6733:
6720:
6719:
6715:
6705:
6703:
6690:
6689:
6685:
6675:
6673:
6660:
6659:
6655:
6645:
6643:
6630:
6629:
6625:
6615:
6613:
6600:
6599:
6595:
6585:
6583:
6570:
6569:
6565:
6555:
6553:
6540:
6539:
6535:
6525:
6523:
6510:
6509:
6505:
6495:
6493:
6480:
6479:
6475:
6465:
6463:
6450:
6449:
6445:
6435:
6433:
6420:
6419:
6415:
6405:
6403:
6390:
6389:
6385:
6375:
6373:
6360:
6359:
6355:
6345:
6343:
6330:
6329:
6325:
6315:
6313:
6300:
6299:
6295:
6285:
6283:
6270:
6269:
6265:
6255:
6253:
6240:
6239:
6235:
6225:
6223:
6210:
6209:
6205:
6195:
6193:
6180:
6179:
6175:
6165:
6163:
6150:
6149:
6145:
6135:
6133:
6120:
6119:
6115:
6105:
6103:
6090:
6089:
6085:
6075:
6073:
6060:
6059:
6055:
6045:
6043:
6030:
6029:
6025:
6015:
6013:
6000:
5999:
5995:
5985:
5983:
5970:
5969:
5965:
5955:
5953:
5940:
5939:
5935:
5925:
5923:
5910:
5909:
5905:
5895:
5893:
5880:
5879:
5875:
5865:
5863:
5850:
5849:
5845:
5833:
5825:
5823:
5810:
5809:
5794:
5784:
5782:
5765:
5764:
5760:
5750:
5748:
5744:
5705:
5700:
5699:
5695:
5683:
5675:
5673:
5660:
5659:
5655:
5645:
5643:
5629:"Zercepac EPAR"
5627:
5626:
5622:
5612:
5610:
5594:
5593:
5589:
5579:
5577:
5561:
5560:
5556:
5546:
5544:
5528:
5527:
5523:
5513:
5511:
5497:"Kanjinti EPAR"
5495:
5494:
5490:
5480:
5478:
5462:
5461:
5457:
5447:
5445:
5429:
5428:
5424:
5414:
5412:
5396:
5395:
5391:
5381:
5379:
5366:
5365:
5361:
5351:
5349:
5333:
5332:
5328:
5318:
5316:
5300:
5299:
5295:
5285:
5283:
5267:
5266:
5262:
5252:
5250:
5234:
5233:
5226:
5216:
5214:
5198:
5197:
5193:
5183:
5181:
5167:"Ruxience EPAR"
5165:
5164:
5160:
5150:
5148:
5132:
5131:
5127:
5117:
5115:
5101:"Rixathon EPAR"
5099:
5098:
5094:
5084:
5082:
5068:"Rituzena EPAR"
5066:
5065:
5061:
5051:
5049:
5035:"Ritemvia EPAR"
5033:
5032:
5028:
5018:
5016:
5002:"Blitzima EPAR"
5000:
4999:
4995:
4985:
4983:
4969:"MabThera EPAR"
4967:
4966:
4962:
4952:
4950:
4934:
4933:
4929:
4919:
4917:
4901:
4900:
4896:
4886:
4884:
4868:
4867:
4863:
4853:
4851:
4837:"Lucentis EPAR"
4835:
4834:
4830:
4820:
4818:
4802:
4801:
4797:
4787:
4785:
4769:
4768:
4764:
4754:
4752:
4736:
4735:
4731:
4721:
4719:
4703:
4702:
4698:
4688:
4686:
4670:
4669:
4665:
4655:
4653:
4637:
4636:
4632:
4622:
4620:
4606:"Fulphila EPAR"
4604:
4603:
4599:
4589:
4587:
4571:
4570:
4566:
4556:
4554:
4540:"Neulasta EPAR"
4538:
4537:
4533:
4523:
4521:
4505:
4504:
4500:
4490:
4488:
4472:
4471:
4467:
4457:
4455:
4439:
4438:
4434:
4424:
4422:
4406:
4405:
4401:
4391:
4389:
4373:
4372:
4368:
4358:
4356:
4340:
4339:
4335:
4325:
4323:
4307:
4306:
4302:
4292:
4290:
4274:
4273:
4269:
4259:
4257:
4241:
4240:
4236:
4226:
4224:
4208:
4207:
4203:
4193:
4191:
4175:
4174:
4170:
4160:
4158:
4142:
4141:
4137:
4127:
4125:
4109:
4108:
4104:
4094:
4092:
4076:
4075:
4071:
4061:
4059:
4043:
4042:
4038:
4028:
4026:
4012:"Remicade EPAR"
4010:
4009:
4005:
3995:
3993:
3977:
3976:
3972:
3962:
3960:
3944:
3943:
3939:
3929:
3927:
3911:
3910:
3906:
3896:
3894:
3878:
3877:
3873:
3863:
3861:
3845:
3844:
3840:
3830:
3828:
3812:
3811:
3807:
3797:
3795:
3779:
3778:
3774:
3764:
3762:
3746:
3745:
3741:
3731:
3729:
3713:
3712:
3708:
3698:
3696:
3680:
3679:
3675:
3665:
3663:
3647:
3646:
3642:
3632:
3630:
3616:"Nivestim EPAR"
3614:
3613:
3606:
3596:
3594:
3578:
3577:
3573:
3563:
3561:
3550:
3549:
3545:
3535:
3533:
3517:
3516:
3512:
3502:
3500:
3486:"Benepali EPAR"
3484:
3483:
3479:
3469:
3467:
3451:
3450:
3446:
3436:
3434:
3418:
3417:
3413:
3403:
3401:
3387:"Retacrit EPAR"
3385:
3384:
3380:
3370:
3368:
3352:
3351:
3347:
3337:
3335:
3321:"Binocrit EPAR"
3319:
3318:
3314:
3304:
3302:
3288:"Abseamed EPAR"
3286:
3285:
3281:
3271:
3269:
3253:
3252:
3248:
3238:
3236:
3220:
3219:
3212:
3202:
3200:
3184:
3183:
3179:
3169:
3167:
3153:"Vegzelma EPAR"
3151:
3150:
3146:
3136:
3134:
3118:
3117:
3113:
3103:
3101:
3085:
3084:
3080:
3070:
3068:
3052:
3051:
3047:
3037:
3035:
3019:
3018:
3014:
3004:
3002:
2988:"Aybintio EPAR"
2986:
2985:
2981:
2971:
2969:
2953:
2952:
2948:
2938:
2936:
2920:
2919:
2915:
2905:
2903:
2887:
2886:
2882:
2872:
2870:
2854:
2853:
2849:
2839:
2837:
2821:
2820:
2816:
2806:
2804:
2790:"Solymbic EPAR"
2788:
2787:
2783:
2773:
2771:
2757:"Libmyris EPAR"
2755:
2754:
2750:
2740:
2738:
2722:
2721:
2717:
2707:
2705:
2689:
2688:
2684:
2674:
2672:
2656:
2655:
2651:
2641:
2639:
2623:
2622:
2618:
2608:
2606:
2590:
2589:
2585:
2575:
2573:
2559:"Hukyndra EPAR"
2557:
2556:
2552:
2542:
2540:
2524:
2523:
2519:
2509:
2507:
2491:
2490:
2486:
2476:
2474:
2458:
2457:
2453:
2443:
2441:
2425:
2424:
2420:
2410:
2408:
2394:"Amgevita EPAR"
2392:
2391:
2387:
2377:
2375:
2359:
2358:
2354:
2344:
2342:
2338:
2327:
2323:
2322:
2318:
2308:
2306:
2290:
2289:
2285:
2239:
2238:
2234:
2224:
2222:
2213:
2212:
2208:
2198:
2196:
2192:
2185:
2181:
2180:
2176:
2159:
2158:
2154:
2144:
2142:
2133:
2132:
2128:
2118:
2116:
2103:
2102:
2098:
2088:
2086:
2073:
2072:
2068:
2058:
2056:
2052:
2041:
2036:
2035:
2028:
2018:
2016:
1999:
1998:
1994:
1958:
1957:
1953:
1943:
1941:
1923:
1922:
1918:
1874:
1873:
1869:
1864:Wayback Machine
1855:
1851:
1839:
1831:
1829:
1812:
1811:
1804:
1783:
1782:
1778:
1768:
1766:
1762:
1747:
1743:
1742:
1738:
1717:
1716:
1712:
1691:
1690:
1686:
1681:Wayback Machine
1672:
1668:
1658:
1656:
1647:
1646:
1642:
1632:
1630:
1614:
1613:
1609:
1599:
1597:
1593:
1582:
1578:
1577:
1573:
1563:
1561:
1557:
1546:
1542:
1541:
1537:
1527:
1525:
1521:
1510:
1506:
1505:
1501:
1491:
1489:
1485:
1474:
1470:
1469:
1465:
1429:
1428:
1424:
1416:
1405:
1401:
1400:
1396:
1366:
1365:
1358:
1353:
1349:
1344:
652:
621:
616:
356:
312:
303:
284:
200:recombinant DNA
196:
142:
137:
84:(FDA), and the
41:(also known as
35:
28:
23:
22:
15:
12:
11:
5:
7515:
7513:
7505:
7504:
7499:
7489:
7488:
7484:
7483:
7463:
7462:
7453:
7444:
7433:
7432:External links
7430:
7429:
7428:
7400:(10): 771–80.
7385:
7346:
7343:
7340:
7339:
7309:
7283:
7253:
7223:
7193:
7163:
7133:
7103:
7073:
7043:
7013:
6983:
6953:
6923:
6893:
6863:
6833:
6803:
6773:
6743:
6713:
6683:
6653:
6623:
6593:
6563:
6533:
6503:
6473:
6443:
6413:
6383:
6353:
6323:
6293:
6263:
6233:
6203:
6173:
6143:
6113:
6083:
6053:
6023:
5993:
5963:
5933:
5903:
5873:
5843:
5792:
5758:
5716:(12): 1856–9.
5693:
5653:
5620:
5587:
5554:
5521:
5488:
5464:"Herzuma EPAR"
5455:
5422:
5389:
5359:
5335:"Terrosa EPAR"
5326:
5302:"Movymia EPAR"
5293:
5269:"Forsteo EPAR"
5260:
5224:
5200:"Truxima EPAR"
5191:
5158:
5134:"Riximyo EPAR"
5125:
5092:
5059:
5026:
4993:
4960:
4936:"Ximluci EPAR"
4927:
4894:
4870:"Byooviz EPAR"
4861:
4828:
4795:
4762:
4729:
4696:
4672:"Pelgraz EPAR"
4663:
4630:
4597:
4564:
4531:
4498:
4474:"Humalog EPAR"
4465:
4441:"Semglee EPAR"
4432:
4399:
4366:
4342:"Ryzodeg EPAR"
4333:
4309:"NovoMix EPAR"
4300:
4267:
4234:
4201:
4168:
4135:
4111:"Remsima EPAR"
4102:
4069:
4045:"Flixabi EPAR"
4036:
4003:
3979:"Ovaleap EPAR"
3970:
3946:"Bemfola EPAR"
3937:
3913:"Gonal-f EPAR"
3904:
3871:
3838:
3805:
3772:
3739:
3706:
3673:
3649:"Accofil EPAR"
3640:
3604:
3580:"Nepexto EPAR"
3571:
3552:"Lifmior EPAR"
3543:
3510:
3477:
3444:
3411:
3378:
3345:
3312:
3279:
3246:
3210:
3186:"Zirabev EPAR"
3177:
3144:
3111:
3087:"Onbevzi EPAR"
3078:
3045:
3012:
2979:
2955:"Alymsys EPAR"
2946:
2913:
2889:"Avastin EPAR"
2880:
2856:"Yuflyma EPAR"
2847:
2823:"Trudexa EPAR"
2814:
2781:
2748:
2724:"Kromeya EPAR"
2715:
2691:"Imraldi EPAR"
2682:
2649:
2625:"Hyrimoz EPAR"
2616:
2583:
2550:
2517:
2484:
2460:"Cyltezo EPAR"
2451:
2418:
2385:
2352:
2316:
2283:
2232:
2206:
2174:
2152:
2126:
2096:
2066:
2026:
1992:
1951:
1916:
1867:
1849:
1802:
1776:
1736:
1710:
1684:
1666:
1640:
1607:
1571:
1535:
1499:
1463:
1442:(4): 369–379.
1422:
1394:
1375:(3): 145–152.
1356:
1346:
1345:
1343:
1340:
1337:
1336:
1330:
1327:
1323:
1322:
1316:
1313:
1309:
1308:
1302:
1299:
1295:
1294:
1288:
1285:
1281:
1280:
1274:
1271:
1267:
1266:
1260:
1257:
1256:September 2023
1253:
1252:
1246:
1243:
1239:
1238:
1232:
1229:
1225:
1224:
1218:
1215:
1211:
1210:
1204:
1201:
1200:September 2022
1197:
1196:
1190:
1187:
1186:September 2022
1183:
1182:
1176:
1173:
1169:
1168:
1162:
1159:
1155:
1154:
1148:
1145:
1141:
1140:
1134:
1131:
1127:
1126:
1120:
1117:
1113:
1112:
1106:
1103:
1099:
1098:
1092:
1089:
1088:September 2021
1085:
1084:
1078:
1075:
1071:
1070:
1064:
1061:
1057:
1056:
1050:
1047:
1043:
1042:
1036:
1033:
1029:
1028:
1022:
1019:
1015:
1014:
1008:
1005:
1001:
1000:
994:
991:
987:
986:
980:
977:
973:
972:
966:
963:
959:
958:
952:
949:
945:
944:
938:
935:
931:
930:
924:
921:
917:
916:
910:
907:
903:
902:
896:
893:
889:
888:
882:
879:
875:
874:
868:
865:
861:
860:
854:
851:
847:
846:
840:
837:
833:
832:
826:
823:
819:
818:
812:
809:
805:
804:
798:
795:
791:
790:
784:
781:
777:
776:
770:
767:
763:
762:
756:
753:
752:September 2017
749:
748:
742:
739:
735:
734:
728:
725:
721:
720:
714:
711:
710:September 2016
707:
706:
700:
697:
693:
692:
686:
683:
679:
678:
672:
669:
665:
664:
661:
658:
651:
648:
629:Edward Kennedy
620:
617:
615:
612:
609:
608:
605:
602:
596:
595:
592:
589:
583:
582:
579:
576:
570:
569:
566:
563:
557:
556:
553:
550:
544:
543:
540:
537:
531:
530:
527:
524:
518:
517:
514:
511:
509:Insulin lispro
505:
504:
501:
498:
492:
491:
488:
485:
483:Insulin aspart
479:
478:
475:
472:
466:
465:
462:
459:
453:
452:
449:
446:
440:
439:
436:
433:
427:
426:
423:
420:
414:
413:
410:
407:
401:
400:
397:
394:
388:
387:
384:
381:
375:
374:
371:
368:
355:
354:European Union
352:
351:
350:
344:
338:
328:
321:
320:
311:
308:
302:
299:
283:
280:
239:erythropoietin
231:growth hormone
195:
192:
141:
138:
136:
133:
95:immunogenicity
67:small-molecule
26:
24:
14:
13:
10:
9:
6:
4:
3:
2:
7514:
7503:
7500:
7498:
7495:
7494:
7492:
7482:
7472:
7468:
7461:
7457:
7454:
7452:
7448:
7445:
7443:
7439:
7436:
7435:
7431:
7425:
7421:
7417:
7413:
7408:
7403:
7399:
7395:
7391:
7386:
7382:
7378:
7374:
7370:
7366:
7362:
7358:
7354:
7349:
7348:
7344:
7327:
7323:
7319:
7313:
7310:
7297:
7293:
7287:
7284:
7271:
7267:
7263:
7257:
7254:
7241:
7237:
7233:
7227:
7224:
7211:
7207:
7203:
7197:
7194:
7181:
7177:
7173:
7167:
7164:
7151:
7147:
7143:
7137:
7134:
7126:September 28,
7121:
7117:
7113:
7107:
7104:
7091:
7087:
7083:
7077:
7074:
7061:
7057:
7053:
7047:
7044:
7031:
7027:
7023:
7017:
7014:
7001:
6997:
6993:
6987:
6984:
6971:
6967:
6963:
6957:
6954:
6941:
6937:
6933:
6927:
6924:
6911:
6907:
6903:
6897:
6894:
6881:
6877:
6873:
6867:
6864:
6851:
6847:
6843:
6837:
6834:
6821:
6817:
6813:
6807:
6804:
6791:
6787:
6783:
6777:
6774:
6761:
6757:
6753:
6747:
6744:
6731:
6727:
6723:
6717:
6714:
6701:
6697:
6693:
6687:
6684:
6671:
6667:
6663:
6657:
6654:
6641:
6637:
6633:
6627:
6624:
6611:
6607:
6603:
6597:
6594:
6581:
6577:
6573:
6567:
6564:
6551:
6547:
6543:
6537:
6534:
6521:
6517:
6513:
6507:
6504:
6491:
6487:
6483:
6477:
6474:
6461:
6457:
6453:
6447:
6444:
6431:
6427:
6423:
6417:
6414:
6401:
6397:
6393:
6387:
6384:
6371:
6367:
6363:
6357:
6354:
6341:
6337:
6333:
6327:
6324:
6311:
6307:
6303:
6297:
6294:
6281:
6277:
6273:
6267:
6264:
6251:
6247:
6243:
6237:
6234:
6221:
6217:
6213:
6207:
6204:
6191:
6187:
6183:
6177:
6174:
6161:
6157:
6153:
6147:
6144:
6131:
6127:
6123:
6117:
6114:
6101:
6097:
6093:
6087:
6084:
6071:
6067:
6063:
6057:
6054:
6041:
6037:
6033:
6027:
6024:
6011:
6007:
6003:
5997:
5994:
5981:
5977:
5973:
5967:
5964:
5951:
5947:
5943:
5937:
5934:
5921:
5917:
5913:
5907:
5904:
5891:
5887:
5883:
5877:
5874:
5861:
5857:
5853:
5847:
5844:
5840:
5839:public domain
5821:
5817:
5813:
5807:
5805:
5803:
5801:
5799:
5797:
5793:
5780:
5776:
5774:
5768:
5762:
5759:
5751:September 25,
5743:
5739:
5735:
5731:
5727:
5723:
5719:
5715:
5711:
5704:
5697:
5694:
5690:
5689:public domain
5671:
5667:
5663:
5662:"Biosimilars"
5657:
5654:
5641:
5637:
5635:
5630:
5624:
5621:
5608:
5604:
5602:
5597:
5591:
5588:
5575:
5571:
5569:
5564:
5558:
5555:
5542:
5538:
5536:
5531:
5530:"Ogivri EPAR"
5525:
5522:
5509:
5505:
5503:
5498:
5492:
5489:
5476:
5472:
5470:
5465:
5459:
5456:
5443:
5439:
5437:
5432:
5426:
5423:
5410:
5406:
5404:
5399:
5398:"Tyenne EPAR"
5393:
5390:
5377:
5373:
5369:
5363:
5360:
5347:
5343:
5341:
5336:
5330:
5327:
5314:
5310:
5308:
5303:
5297:
5294:
5281:
5277:
5275:
5270:
5264:
5261:
5248:
5244:
5242:
5237:
5231:
5229:
5225:
5212:
5208:
5206:
5201:
5195:
5192:
5179:
5175:
5173:
5168:
5162:
5159:
5146:
5142:
5140:
5135:
5129:
5126:
5113:
5109:
5107:
5102:
5096:
5093:
5080:
5076:
5074:
5069:
5063:
5060:
5047:
5043:
5041:
5036:
5030:
5027:
5014:
5010:
5008:
5003:
4997:
4994:
4981:
4977:
4975:
4970:
4964:
4961:
4948:
4944:
4942:
4937:
4931:
4928:
4915:
4911:
4909:
4904:
4898:
4895:
4882:
4878:
4876:
4871:
4865:
4862:
4849:
4845:
4843:
4838:
4832:
4829:
4816:
4812:
4810:
4805:
4799:
4796:
4783:
4779:
4777:
4772:
4766:
4763:
4750:
4746:
4744:
4739:
4733:
4730:
4717:
4713:
4711:
4706:
4705:"Pelmeg EPAR"
4700:
4697:
4684:
4680:
4678:
4673:
4667:
4664:
4651:
4647:
4645:
4640:
4634:
4631:
4618:
4614:
4612:
4607:
4601:
4598:
4585:
4581:
4579:
4574:
4568:
4565:
4552:
4548:
4546:
4541:
4535:
4532:
4519:
4515:
4513:
4508:
4502:
4499:
4486:
4482:
4480:
4475:
4469:
4466:
4453:
4449:
4447:
4442:
4436:
4433:
4420:
4416:
4414:
4409:
4403:
4400:
4387:
4383:
4381:
4376:
4375:"Lantus EPAR"
4370:
4367:
4354:
4350:
4348:
4343:
4337:
4334:
4321:
4317:
4315:
4310:
4304:
4301:
4293:September 14,
4288:
4284:
4282:
4277:
4276:"Kirsty EPAR"
4271:
4268:
4255:
4251:
4249:
4244:
4238:
4235:
4222:
4218:
4216:
4211:
4205:
4202:
4189:
4185:
4183:
4178:
4172:
4169:
4156:
4152:
4150:
4145:
4144:"Zessly EPAR"
4139:
4136:
4123:
4119:
4117:
4112:
4106:
4103:
4090:
4086:
4084:
4079:
4073:
4070:
4057:
4053:
4051:
4046:
4040:
4037:
4024:
4020:
4018:
4013:
4007:
4004:
3991:
3987:
3985:
3980:
3974:
3971:
3958:
3954:
3952:
3947:
3941:
3938:
3925:
3921:
3919:
3914:
3908:
3905:
3892:
3888:
3886:
3881:
3880:"Zarzio EPAR"
3875:
3872:
3859:
3855:
3853:
3848:
3842:
3839:
3826:
3822:
3820:
3815:
3809:
3806:
3793:
3789:
3787:
3782:
3776:
3773:
3760:
3756:
3754:
3749:
3743:
3740:
3727:
3723:
3721:
3716:
3710:
3707:
3694:
3690:
3688:
3683:
3677:
3674:
3661:
3657:
3655:
3650:
3644:
3641:
3628:
3624:
3622:
3617:
3611:
3609:
3605:
3592:
3588:
3586:
3581:
3575:
3572:
3560:
3558:
3553:
3547:
3544:
3531:
3527:
3525:
3520:
3519:"Erelzi EPAR"
3514:
3511:
3498:
3494:
3492:
3487:
3481:
3478:
3465:
3461:
3459:
3454:
3453:"Enbrel EPAR"
3448:
3445:
3432:
3428:
3426:
3421:
3420:"Silapo EPAR"
3415:
3412:
3399:
3395:
3393:
3388:
3382:
3379:
3366:
3362:
3360:
3355:
3349:
3346:
3333:
3329:
3327:
3322:
3316:
3313:
3300:
3296:
3294:
3289:
3283:
3280:
3267:
3263:
3261:
3256:
3250:
3247:
3234:
3230:
3228:
3223:
3222:"Inhixa EPAR"
3217:
3215:
3211:
3198:
3194:
3192:
3187:
3181:
3178:
3165:
3161:
3159:
3154:
3148:
3145:
3137:September 11,
3132:
3128:
3126:
3121:
3120:"Oyavas EPAR"
3115:
3112:
3104:September 11,
3099:
3095:
3093:
3088:
3082:
3079:
3066:
3062:
3060:
3055:
3049:
3046:
3033:
3029:
3027:
3022:
3016:
3013:
3000:
2996:
2994:
2989:
2983:
2980:
2972:September 11,
2967:
2963:
2961:
2956:
2950:
2947:
2934:
2930:
2928:
2923:
2922:"Abevmy EPAR"
2917:
2914:
2906:September 11,
2901:
2897:
2895:
2890:
2884:
2881:
2868:
2864:
2862:
2857:
2851:
2848:
2835:
2831:
2829:
2824:
2818:
2815:
2802:
2798:
2796:
2791:
2785:
2782:
2769:
2765:
2763:
2758:
2752:
2749:
2736:
2732:
2730:
2725:
2719:
2716:
2703:
2699:
2697:
2692:
2686:
2683:
2670:
2666:
2664:
2659:
2658:"Idacio EPAR"
2653:
2650:
2637:
2633:
2631:
2626:
2620:
2617:
2604:
2600:
2598:
2593:
2587:
2584:
2571:
2567:
2565:
2560:
2554:
2551:
2538:
2534:
2532:
2527:
2526:"Hefiya EPAR"
2521:
2518:
2505:
2501:
2499:
2494:
2488:
2485:
2472:
2468:
2466:
2461:
2455:
2452:
2439:
2435:
2433:
2428:
2422:
2419:
2406:
2402:
2400:
2395:
2389:
2386:
2373:
2369:
2367:
2362:
2361:"Humira EPAR"
2356:
2353:
2337:
2333:
2326:
2320:
2317:
2309:September 19,
2304:
2300:
2298:
2293:
2287:
2284:
2279:
2275:
2270:
2265:
2260:
2255:
2251:
2247:
2243:
2236:
2233:
2220:
2216:
2210:
2207:
2191:
2184:
2178:
2175:
2170:
2166:
2162:
2156:
2153:
2140:
2136:
2130:
2127:
2114:
2110:
2106:
2100:
2097:
2084:
2080:
2076:
2070:
2067:
2051:
2047:
2040:
2033:
2031:
2027:
2014:
2010:
2008:
2002:
1996:
1993:
1988:
1984:
1979:
1974:
1970:
1966:
1962:
1955:
1952:
1939:
1935:
1931:
1927:
1920:
1917:
1912:
1908:
1903:
1898:
1894:
1890:
1886:
1882:
1878:
1871:
1868:
1865:
1861:
1858:
1853:
1850:
1846:
1845:public domain
1827:
1823:
1821:
1815:
1809:
1807:
1803:
1798:
1794:
1792:
1786:
1780:
1777:
1761:
1757:
1755:
1746:
1740:
1737:
1732:
1728:
1726:
1720:
1714:
1711:
1706:
1702:
1700:
1694:
1688:
1685:
1682:
1678:
1675:
1670:
1667:
1654:
1650:
1644:
1641:
1628:
1624:
1622:
1617:
1611:
1608:
1592:
1589:(WHO). 2017.
1588:
1581:
1575:
1572:
1556:
1553:(WHO). 2018.
1552:
1545:
1539:
1536:
1520:
1517:(WHO). 2013.
1516:
1509:
1503:
1500:
1484:
1480:
1473:
1467:
1464:
1459:
1455:
1450:
1445:
1441:
1437:
1433:
1426:
1423:
1415:
1411:
1404:
1398:
1395:
1390:
1386:
1382:
1378:
1374:
1370:
1363:
1361:
1357:
1351:
1348:
1341:
1334:
1331:
1328:
1325:
1324:
1320:
1317:
1314:
1311:
1310:
1306:
1303:
1300:
1298:February 2024
1297:
1296:
1292:
1289:
1286:
1284:December 2023
1283:
1282:
1278:
1275:
1272:
1269:
1268:
1264:
1261:
1258:
1255:
1254:
1250:
1247:
1244:
1241:
1240:
1236:
1233:
1230:
1227:
1226:
1222:
1219:
1216:
1214:December 2022
1213:
1212:
1208:
1205:
1202:
1199:
1198:
1194:
1193:pegfilgrastim
1191:
1188:
1185:
1184:
1180:
1177:
1174:
1171:
1170:
1166:
1165:pegfilgrastim
1163:
1160:
1157:
1156:
1152:
1149:
1146:
1143:
1142:
1138:
1135:
1132:
1130:February 2022
1129:
1128:
1124:
1121:
1118:
1116:December 2021
1115:
1114:
1110:
1107:
1104:
1102:December 2021
1101:
1100:
1096:
1093:
1090:
1087:
1086:
1082:
1079:
1076:
1073:
1072:
1068:
1065:
1062:
1060:December 2020
1059:
1058:
1054:
1051:
1048:
1045:
1044:
1040:
1039:pegfilgrastim
1037:
1034:
1031:
1030:
1026:
1023:
1020:
1018:December 2019
1017:
1016:
1012:
1009:
1006:
1004:November 2019
1003:
1002:
998:
997:pegfilgrastim
995:
992:
990:November 2019
989:
988:
984:
981:
978:
975:
974:
970:
967:
964:
961:
960:
956:
953:
950:
947:
946:
942:
939:
936:
933:
932:
928:
925:
922:
919:
918:
914:
911:
908:
905:
904:
900:
897:
894:
891:
890:
886:
883:
880:
878:December 2018
877:
876:
872:
869:
866:
864:November 2018
863:
862:
858:
857:pegfilgrastim
855:
852:
850:November 2018
849:
848:
844:
841:
838:
835:
834:
830:
827:
824:
821:
820:
816:
815:pegfilgrastim
813:
810:
807:
806:
802:
799:
796:
793:
792:
788:
785:
782:
780:December 2017
779:
778:
774:
771:
768:
766:December 2017
765:
764:
760:
757:
754:
751:
750:
746:
743:
740:
737:
736:
732:
729:
726:
723:
722:
718:
715:
712:
709:
708:
704:
701:
698:
695:
694:
690:
687:
684:
681:
680:
676:
673:
670:
667:
666:
662:
659:
656:
655:
649:
647:
645:
640:
638:
634:
630:
626:
618:
614:United States
613:
606:
603:
601:
598:
597:
593:
590:
588:
585:
584:
580:
577:
575:
572:
571:
567:
564:
562:
559:
558:
554:
551:
549:
546:
545:
541:
538:
536:
533:
532:
528:
525:
523:
522:Pegfilgrastim
520:
519:
515:
512:
510:
507:
506:
502:
499:
497:
494:
493:
489:
486:
484:
481:
480:
476:
473:
471:
468:
467:
463:
460:
458:
455:
454:
450:
447:
445:
442:
441:
437:
434:
432:
429:
428:
424:
421:
419:
416:
415:
411:
408:
406:
403:
402:
398:
395:
393:
390:
389:
385:
382:
380:
377:
376:
372:
369:
366:
365:
359:
353:
348:
345:
342:
339:
336:
332:
331:Reimbursement
329:
326:
323:
322:
318:
317:
316:
309:
307:
300:
298:
296:
291:
287:
281:
279:
275:
271:
268:
262:
258:
255:
250:
246:
244:
240:
236:
232:
228:
223:
220:
215:
213:
209:
205:
201:
193:
191:
187:
185:
180:
175:
173:
169:
165:
161:
156:
154:
149:
147:
140:United States
139:
134:
132:
130:
126:
122:
118:
113:
111:
106:
104:
100:
96:
91:
90:Health Canada
87:
83:
79:
74:
72:
68:
64:
63:generic drugs
59:
57:
52:
48:
44:
40:
33:
19:
7397:
7393:
7356:
7352:
7332:November 13,
7330:. Retrieved
7312:
7302:November 26,
7300:. Retrieved
7286:
7276:November 26,
7274:. Retrieved
7256:
7244:. Retrieved
7226:
7214:. Retrieved
7196:
7184:. Retrieved
7166:
7154:. Retrieved
7136:
7124:. Retrieved
7106:
7094:. Retrieved
7076:
7064:. Retrieved
7046:
7034:. Retrieved
7016:
7004:. Retrieved
6986:
6974:. Retrieved
6956:
6944:. Retrieved
6926:
6914:. Retrieved
6896:
6884:. Retrieved
6866:
6856:December 17,
6854:. Retrieved
6836:
6826:December 17,
6824:. Retrieved
6806:
6796:December 17,
6794:. Retrieved
6776:
6766:December 17,
6764:. Retrieved
6746:
6736:December 17,
6734:. Retrieved
6716:
6706:December 17,
6704:. Retrieved
6686:
6676:December 17,
6674:. Retrieved
6656:
6646:December 17,
6644:. Retrieved
6626:
6616:December 17,
6614:. Retrieved
6596:
6586:December 17,
6584:. Retrieved
6566:
6556:December 17,
6554:. Retrieved
6536:
6526:December 17,
6524:. Retrieved
6506:
6496:December 17,
6494:. Retrieved
6476:
6466:December 17,
6464:. Retrieved
6446:
6436:December 17,
6434:. Retrieved
6416:
6406:December 17,
6404:. Retrieved
6386:
6376:December 17,
6374:. Retrieved
6356:
6346:November 26,
6344:. Retrieved
6326:
6316:December 17,
6314:. Retrieved
6296:
6286:November 26,
6284:. Retrieved
6266:
6256:December 17,
6254:. Retrieved
6236:
6226:December 17,
6224:. Retrieved
6206:
6196:November 26,
6194:. Retrieved
6176:
6166:December 17,
6164:. Retrieved
6146:
6136:November 26,
6134:. Retrieved
6116:
6106:December 17,
6104:. Retrieved
6086:
6074:. Retrieved
6056:
6046:December 17,
6044:. Retrieved
6026:
6016:November 26,
6014:. Retrieved
5996:
5986:December 17,
5984:. Retrieved
5966:
5956:November 26,
5954:. Retrieved
5936:
5926:December 17,
5924:. Retrieved
5906:
5896:November 26,
5894:. Retrieved
5876:
5866:December 17,
5864:. Retrieved
5846:
5824:. Retrieved
5785:December 16,
5783:. Retrieved
5770:
5761:
5749:. Retrieved
5742:the original
5713:
5709:
5696:
5674:. Retrieved
5665:
5656:
5644:. Retrieved
5632:
5623:
5611:. Retrieved
5599:
5590:
5578:. Retrieved
5566:
5557:
5545:. Retrieved
5533:
5524:
5512:. Retrieved
5500:
5491:
5479:. Retrieved
5467:
5458:
5446:. Retrieved
5434:
5425:
5413:. Retrieved
5401:
5392:
5380:. Retrieved
5371:
5362:
5350:. Retrieved
5338:
5329:
5317:. Retrieved
5305:
5296:
5284:. Retrieved
5272:
5263:
5251:. Retrieved
5239:
5217:September 8,
5215:. Retrieved
5203:
5194:
5184:September 8,
5182:. Retrieved
5170:
5161:
5151:September 8,
5149:. Retrieved
5137:
5128:
5118:September 8,
5116:. Retrieved
5104:
5095:
5085:September 8,
5083:. Retrieved
5071:
5062:
5052:September 8,
5050:. Retrieved
5038:
5029:
5019:September 8,
5017:. Retrieved
5005:
4996:
4986:September 8,
4984:. Retrieved
4972:
4963:
4951:. Retrieved
4939:
4930:
4918:. Retrieved
4906:
4897:
4887:September 9,
4885:. Retrieved
4873:
4864:
4854:September 9,
4852:. Retrieved
4840:
4831:
4819:. Retrieved
4807:
4798:
4786:. Retrieved
4774:
4765:
4753:. Retrieved
4741:
4732:
4720:. Retrieved
4708:
4699:
4687:. Retrieved
4675:
4666:
4654:. Retrieved
4642:
4633:
4621:. Retrieved
4609:
4600:
4588:. Retrieved
4576:
4567:
4555:. Retrieved
4543:
4534:
4524:September 9,
4522:. Retrieved
4510:
4501:
4489:. Retrieved
4477:
4468:
4456:. Retrieved
4444:
4435:
4423:. Retrieved
4411:
4402:
4390:. Retrieved
4378:
4369:
4357:. Retrieved
4345:
4336:
4324:. Retrieved
4312:
4303:
4291:. Retrieved
4279:
4270:
4260:September 9,
4258:. Retrieved
4246:
4237:
4225:. Retrieved
4213:
4210:"Fiasp EPAR"
4204:
4192:. Retrieved
4180:
4171:
4159:. Retrieved
4147:
4138:
4126:. Retrieved
4114:
4105:
4093:. Retrieved
4081:
4072:
4060:. Retrieved
4048:
4039:
4027:. Retrieved
4015:
4006:
3996:September 9,
3994:. Retrieved
3982:
3973:
3963:September 9,
3961:. Retrieved
3949:
3940:
3928:. Retrieved
3916:
3907:
3895:. Retrieved
3883:
3874:
3862:. Retrieved
3850:
3841:
3829:. Retrieved
3817:
3808:
3796:. Retrieved
3784:
3775:
3763:. Retrieved
3751:
3742:
3730:. Retrieved
3718:
3709:
3697:. Retrieved
3685:
3676:
3664:. Retrieved
3652:
3643:
3631:. Retrieved
3619:
3595:. Retrieved
3583:
3574:
3562:. Retrieved
3555:
3546:
3534:. Retrieved
3522:
3513:
3501:. Retrieved
3489:
3480:
3468:. Retrieved
3456:
3447:
3435:. Retrieved
3423:
3414:
3402:. Retrieved
3390:
3381:
3369:. Retrieved
3357:
3348:
3336:. Retrieved
3324:
3315:
3303:. Retrieved
3291:
3282:
3270:. Retrieved
3258:
3249:
3239:September 9,
3237:. Retrieved
3225:
3201:. Retrieved
3189:
3180:
3168:. Retrieved
3156:
3147:
3135:. Retrieved
3123:
3114:
3102:. Retrieved
3090:
3081:
3069:. Retrieved
3057:
3054:"Mvasi EPAR"
3048:
3036:. Retrieved
3024:
3015:
3005:September 9,
3003:. Retrieved
2991:
2982:
2970:. Retrieved
2958:
2949:
2937:. Retrieved
2925:
2916:
2904:. Retrieved
2892:
2883:
2871:. Retrieved
2859:
2850:
2838:. Retrieved
2826:
2817:
2805:. Retrieved
2793:
2784:
2772:. Retrieved
2760:
2751:
2739:. Retrieved
2727:
2718:
2706:. Retrieved
2694:
2685:
2673:. Retrieved
2661:
2652:
2640:. Retrieved
2628:
2619:
2607:. Retrieved
2595:
2592:"Hulio EPAR"
2586:
2574:. Retrieved
2562:
2553:
2541:. Retrieved
2529:
2520:
2508:. Retrieved
2496:
2487:
2475:. Retrieved
2463:
2454:
2442:. Retrieved
2430:
2421:
2409:. Retrieved
2397:
2388:
2376:. Retrieved
2364:
2355:
2343:. Retrieved
2331:
2319:
2307:. Retrieved
2295:
2286:
2249:
2245:
2235:
2225:December 30,
2223:. Retrieved
2209:
2197:. Retrieved
2177:
2169:the original
2164:
2155:
2145:December 29,
2143:. Retrieved
2129:
2119:December 29,
2117:. Retrieved
2108:
2099:
2089:December 20,
2087:. Retrieved
2078:
2069:
2059:December 23,
2057:. Retrieved
2045:
2017:. Retrieved
2004:
1995:
1971:(2): 153–6.
1968:
1964:
1954:
1942:. Retrieved
1936:(6): 32–37.
1933:
1929:
1919:
1884:
1880:
1870:
1852:
1832:December 17,
1830:. Retrieved
1817:
1797:the original
1788:
1779:
1769:December 16,
1767:. Retrieved
1751:
1739:
1731:the original
1722:
1713:
1705:the original
1696:
1687:
1669:
1657:. Retrieved
1653:the original
1643:
1631:. Retrieved
1619:
1610:
1600:December 18,
1598:. Retrieved
1574:
1564:December 18,
1562:. Retrieved
1538:
1528:December 18,
1526:. Retrieved
1502:
1490:. Retrieved
1483:the original
1466:
1439:
1435:
1425:
1414:the original
1409:
1397:
1372:
1368:
1350:
1270:October 2023
892:January 2019
836:October 2018
801:epoetin alfa
644:evergreening
641:
622:
574:Teriparatide
418:Epoetin alfa
357:
346:
340:
330:
324:
313:
304:
292:
288:
285:
282:Nomenclature
276:
272:
263:
259:
251:
247:
224:
216:
197:
188:
176:
157:
150:
143:
114:
107:
75:
61:Unlike with
60:
46:
42:
38:
36:
7359:(1): 13–4.
3038:October 12,
1887:(1): 7–14.
1492:October 24,
1291:bevacizumab
1277:ustekinumab
1263:tocilizumab
1249:natalizumab
1242:August 2023
1207:bevacizumab
1179:ranibizumab
1172:August 2022
1151:bevacizumab
1095:ranibizumab
955:bevacizumab
943:/Herceptin
941:trastuzumab
915:/Herceptin
913:trastuzumab
901:/Herceptin
899:trastuzumab
887:/Herceptin
885:trastuzumab
775:/Herceptin
773:trastuzumab
759:bevacizumab
738:August 2017
696:August 2016
600:Trastuzumab
587:Tocilizumab
535:Ranibizumab
422:Eprex/Erypo
392:Bevacizumab
235:interferons
18:Biosimilars
7491:Categories
7246:August 25,
7216:August 25,
7186:August 25,
7156:August 25,
7096:August 25,
6946:August 25,
6886:August 28,
6076:August 28,
5826:August 28,
5676:August 28,
4920:October 6,
4359:August 27,
4326:August 27,
4227:August 27,
2939:August 27,
2873:August 27,
2840:August 27,
2807:August 27,
2741:August 27,
2477:August 27,
1944:August 13,
1659:October 8,
1585:(Report).
1549:(Report).
1513:(Report).
1477:(Report).
1342:References
1326:March 2024
1312:March 2024
1305:adalimumab
1235:adalimumab
1221:adalimumab
1195:/Neulasta
1181:/Lucentis
1167:/Neulasta
1144:April 2022
1139:/Neupogen
1137:filgrastim
1123:adalimumab
1097:/Lucentis
1053:adalimumab
1041:/Neulasta
1027:/Remicade
1025:infliximab
1011:adalimumab
999:/Neulasta
983:adalimumab
927:etanercept
920:April 2019
906:March 2019
859:/Neulasta
843:adalimumab
831:/Neupogen
829:filgrastim
817:/Neulasta
789:/Remicade
787:infliximab
745:adalimumab
733:/Remicade
731:infliximab
724:April 2017
717:adalimumab
703:etanercept
691:/Remicade
689:infliximab
682:April 2016
677:/Neupogen
675:filgrastim
668:March 2015
568:Omnitrope
565:Genotropin
561:Somatropin
470:Infliximab
444:Filgrastim
431:Etanercept
379:Adalimumab
212:cell-based
194:Background
168:Genotropin
164:Enoxaparin
125:filgrastim
121:infliximab
39:biosimilar
7424:205293428
4738:"Udenyca"
2774:April 23,
2708:April 21,
2675:April 21,
2642:April 21,
2609:April 21,
2576:April 23,
2543:April 21,
2510:April 21,
2444:April 21,
2411:April 21,
2252:(1): 79.
2199:August 2,
2019:August 2,
1633:April 21,
1369:Pharm Med
1333:denosumab
1319:denosumab
1293:/Avastin
1279:/Stelara
1265:/Actemra
1251:/Tysabri
1209:/Avastin
1153:/Avastin
1074:July 2021
1069:/Rituxan
1067:rituximab
1046:July 2020
1032:June 2020
976:July 2019
971:/Rituxan
969:rituximab
962:July 2019
957:/Avastin
948:June 2019
934:June 2019
873:/Rituxan
871:rituximab
822:July 2018
808:June 2018
803:/Procrit
761:/Avastin
604:Herceptin
591:RoActemra
548:Rituximab
487:NovoRapid
301:Australia
243:biologics
160:Omnitrope
7481:Medicine
7416:20706990
7381:27954836
7373:26678619
7326:Archived
7270:Archived
7240:Archived
7210:Archived
7180:Archived
7150:Archived
7120:Archived
7090:Archived
7060:Archived
7030:Archived
7000:Archived
6970:Archived
6940:Archived
6910:Archived
6880:Archived
6850:Archived
6820:Archived
6790:Archived
6760:Archived
6730:Archived
6700:Archived
6670:Archived
6640:Archived
6610:Archived
6580:Archived
6550:Archived
6520:Archived
6490:Archived
6460:Archived
6430:Archived
6400:Archived
6370:Archived
6340:Archived
6310:Archived
6280:Archived
6250:Archived
6220:Archived
6190:Archived
6160:Archived
6130:Archived
6100:Archived
6070:Archived
6040:Archived
6010:Archived
5980:Archived
5950:Archived
5920:Archived
5890:Archived
5860:Archived
5820:Archived
5779:Archived
5738:19274464
5730:24957160
5670:Archived
5646:July 28,
5640:Archived
5613:July 28,
5607:Archived
5580:July 28,
5574:Archived
5547:July 28,
5541:Archived
5514:July 28,
5508:Archived
5481:July 28,
5475:Archived
5448:July 28,
5442:Archived
5415:March 7,
5409:Archived
5382:March 7,
5376:Archived
5352:April 4,
5346:Archived
5319:April 4,
5313:Archived
5286:March 7,
5280:Archived
5253:April 2,
5247:Archived
5211:Archived
5178:Archived
5145:Archived
5112:Archived
5079:Archived
5046:Archived
5013:Archived
4980:Archived
4953:March 3,
4947:Archived
4914:Archived
4881:Archived
4848:Archived
4821:April 2,
4815:Archived
4788:April 4,
4782:Archived
4755:April 2,
4749:Archived
4722:April 2,
4716:Archived
4689:April 2,
4683:Archived
4656:April 2,
4650:Archived
4623:April 2,
4617:Archived
4590:April 2,
4584:Archived
4557:April 2,
4551:Archived
4518:Archived
4491:March 7,
4485:Archived
4458:April 4,
4452:Archived
4425:April 4,
4419:Archived
4392:March 7,
4386:Archived
4353:Archived
4320:Archived
4287:Archived
4254:Archived
4221:Archived
4194:March 7,
4188:Archived
4161:April 4,
4155:Archived
4128:April 4,
4122:Archived
4095:April 4,
4089:Archived
4062:April 4,
4056:Archived
4029:March 7,
4023:Archived
3990:Archived
3957:Archived
3930:March 7,
3924:Archived
3897:April 4,
3891:Archived
3864:April 4,
3858:Archived
3831:April 4,
3825:Archived
3798:April 4,
3792:Archived
3765:April 2,
3759:Archived
3732:April 4,
3726:Archived
3699:April 2,
3693:Archived
3666:April 4,
3660:Archived
3633:April 4,
3627:Archived
3591:Archived
3564:April 2,
3536:April 4,
3530:Archived
3503:April 4,
3497:Archived
3470:March 7,
3464:Archived
3437:April 4,
3431:Archived
3404:April 4,
3398:Archived
3371:April 4,
3365:Archived
3338:April 4,
3332:Archived
3305:April 4,
3299:Archived
3272:April 2,
3266:Archived
3233:Archived
3203:April 2,
3197:Archived
3170:March 3,
3164:Archived
3131:Archived
3098:Archived
3071:April 2,
3065:Archived
3032:Archived
2999:Archived
2966:Archived
2933:Archived
2900:Archived
2867:Archived
2834:Archived
2801:Archived
2768:Archived
2735:Archived
2702:Archived
2669:Archived
2636:Archived
2603:Archived
2570:Archived
2537:Archived
2504:Archived
2471:Archived
2438:Archived
2405:Archived
2378:March 7,
2372:Archived
2336:Archived
2303:Archived
2278:37365620
2269:10291771
2219:Archived
2190:Archived
2139:Archived
2113:Archived
2083:Archived
2050:Archived
2013:Archived
1987:23286777
1938:Archived
1911:22574725
1860:Archived
1826:Archived
1760:Archived
1677:Archived
1627:Archived
1591:Archived
1555:Archived
1519:Archived
1458:29285958
1389:14604362
1321:/Prolia
1307:/Humira
1237:/Humira
1228:May 2023
1223:/Humira
1158:May 2022
1125:/Humira
1111:/Lantus
1083:/Lantus
1055:/Humira
1013:/Humira
985:/Humira
929:/Enbrel
845:/Humira
794:May 2018
747:/Humira
719:/Humira
705:/Enbrel
619:BPCI Act
552:MabThera
539:Lucentis
526:Neulasta
474:Remicade
448:Neupogen
229:, human
219:proteins
172:biologic
7294:. U.S.
7264:. U.S.
7234:. U.S.
7204:. U.S.
7174:. U.S.
7144:. U.S.
7114:. U.S.
7084:. U.S.
7066:May 27,
7054:. U.S.
7036:May 26,
7024:. U.S.
7006:May 26,
6994:. U.S.
6976:May 26,
6964:. U.S.
6934:. U.S.
6916:May 26,
6904:. U.S.
6874:. U.S.
6844:. U.S.
6814:. U.S.
6784:. U.S.
6754:. U.S.
6724:. U.S.
6694:. U.S.
6664:. U.S.
6634:. U.S.
6604:. U.S.
6574:. U.S.
6544:. U.S.
6514:. U.S.
6484:. U.S.
6454:. U.S.
6424:. U.S.
6394:. U.S.
6364:. U.S.
6334:. U.S.
6308:(FDA).
6274:. U.S.
6248:(FDA).
6214:. U.S.
6184:. U.S.
6158:(FDA).
6124:. U.S.
6098:(FDA).
6068:(FDA).
6064:. U.S.
6034:. U.S.
6004:. U.S.
5978:(FDA).
5944:. U.S.
5918:(FDA).
5884:. U.S.
5854:. U.S.
5818:(FDA).
5814:. U.S.
3597:June 4,
2345:June 9,
1902:3555041
1335:/Xgeva
594:Tyenne
578:Forsteo
513:Humalog
461:Gonal-F
409:Clexane
396:Avastin
325:Pricing
227:insulin
49:) is a
7467:Portal
7422:
7414:
7379:
7371:
5736:
5728:
2276:
2266:
2048:(50).
1985:
1909:
1899:
1456:
1387:
500:Lantus
435:Enbrel
383:Humira
341:Uptake
184:Zarxio
179:Zarxio
129:Sandoz
56:patent
7458:U.S.
7449:U.S.
7440:U.S.
7420:S2CID
7377:S2CID
5775:(FDA)
5771:U.S.
5745:(PDF)
5734:S2CID
5706:(PDF)
5636:(EMA)
5603:(EMA)
5570:(EMA)
5537:(EMA)
5504:(EMA)
5471:(EMA)
5438:(EMA)
5405:(EMA)
5342:(EMA)
5309:(EMA)
5276:(EMA)
5243:(EMA)
5207:(EMA)
5174:(EMA)
5141:(EMA)
5108:(EMA)
5075:(EMA)
5042:(EMA)
5009:(EMA)
4976:(EMA)
4943:(EMA)
4910:(EMA)
4877:(EMA)
4844:(EMA)
4811:(EMA)
4778:(EMA)
4712:(EMA)
4679:(EMA)
4646:(EMA)
4613:(EMA)
4580:(EMA)
4547:(EMA)
4514:(EMA)
4481:(EMA)
4448:(EMA)
4415:(EMA)
4382:(EMA)
4349:(EMA)
4316:(EMA)
4283:(EMA)
4250:(EMA)
4217:(EMA)
4184:(EMA)
4151:(EMA)
4118:(EMA)
4085:(EMA)
4052:(EMA)
4019:(EMA)
3986:(EMA)
3953:(EMA)
3920:(EMA)
3887:(EMA)
3854:(EMA)
3821:(EMA)
3788:(EMA)
3755:(EMA)
3722:(EMA)
3689:(EMA)
3656:(EMA)
3623:(EMA)
3587:(EMA)
3559:(EMA)
3526:(EMA)
3493:(EMA)
3460:(EMA)
3427:(EMA)
3394:(EMA)
3361:(EMA)
3328:(EMA)
3295:(EMA)
3262:(EMA)
3229:(EMA)
3193:(EMA)
3160:(EMA)
3127:(EMA)
3094:(EMA)
3061:(EMA)
3028:(EMA)
2995:(EMA)
2962:(EMA)
2929:(EMA)
2896:(EMA)
2863:(EMA)
2830:(EMA)
2797:(EMA)
2764:(EMA)
2731:(EMA)
2698:(EMA)
2665:(EMA)
2632:(EMA)
2599:(EMA)
2566:(EMA)
2533:(EMA)
2500:(EMA)
2467:(EMA)
2434:(EMA)
2401:(EMA)
2368:(EMA)
2339:(PDF)
2328:(PDF)
2299:(EMA)
2193:(PDF)
2186:(PDF)
2053:(PDF)
2042:(PDF)
2009:(FDA)
2005:U.S.
1822:(FDA)
1818:U.S.
1793:(FDA)
1789:U.S.
1763:(PDF)
1756:(FDA)
1752:U.S.
1748:(PDF)
1727:(FDA)
1723:U.S.
1701:(FDA)
1697:U.S.
1623:(EMA)
1594:(PDF)
1583:(PDF)
1558:(PDF)
1547:(PDF)
1522:(PDF)
1511:(PDF)
1486:(PDF)
1475:(PDF)
1417:(PDF)
1406:(PDF)
1385:S2CID
310:Egypt
208:Gene-
7412:PMID
7369:PMID
7334:2023
7304:2023
7278:2023
7248:2023
7218:2023
7188:2023
7158:2023
7128:2022
7098:2023
7068:2022
7038:2022
7008:2022
6978:2022
6948:2023
6918:2022
6888:2021
6858:2020
6828:2020
6798:2020
6768:2020
6738:2020
6708:2019
6678:2019
6648:2019
6618:2019
6588:2019
6558:2019
6528:2019
6498:2019
6468:2019
6438:2019
6408:2019
6378:2019
6348:2023
6318:2020
6288:2023
6258:2020
6228:2019
6198:2023
6168:2020
6138:2023
6108:2020
6078:2017
6048:2019
6018:2023
5988:2020
5958:2023
5928:2020
5898:2023
5868:2019
5828:2021
5787:2018
5753:2016
5726:PMID
5678:2021
5648:2020
5615:2020
5582:2020
5549:2020
5516:2020
5483:2020
5450:2020
5417:2024
5384:2024
5354:2022
5321:2022
5288:2024
5255:2020
5219:2021
5186:2021
5153:2021
5120:2021
5087:2021
5054:2021
5021:2021
4988:2021
4955:2023
4922:2022
4889:2021
4856:2021
4823:2020
4790:2022
4757:2020
4745:(EMA
4724:2020
4691:2020
4658:2020
4625:2020
4592:2020
4559:2020
4526:2020
4493:2024
4460:2022
4427:2022
4394:2024
4361:2021
4328:2021
4295:2021
4262:2020
4229:2021
4196:2024
4163:2022
4130:2022
4097:2022
4064:2022
4031:2024
3998:2020
3965:2020
3932:2024
3899:2022
3866:2022
3833:2022
3800:2022
3767:2020
3734:2022
3701:2020
3668:2022
3635:2022
3599:2020
3566:2020
3538:2022
3505:2022
3472:2024
3439:2022
3406:2022
3373:2022
3340:2022
3307:2022
3274:2020
3241:2020
3205:2020
3172:2023
3139:2021
3106:2021
3073:2020
3040:2020
3007:2020
2974:2021
2941:2021
2908:2021
2875:2021
2842:2021
2809:2021
2776:2022
2743:2021
2710:2020
2677:2020
2644:2020
2611:2020
2578:2022
2545:2020
2512:2020
2479:2021
2446:2020
2413:2020
2380:2024
2347:2020
2311:2022
2274:PMID
2227:2021
2201:2019
2147:2021
2121:2021
2091:2021
2061:2020
2021:2018
1983:PMID
1946:2014
1907:PMID
1834:2019
1771:2019
1661:2007
1635:2020
1602:2019
1566:2019
1530:2019
1494:2019
1454:PMID
623:The
210:and
108:The
97:and
7402:doi
7361:doi
5718:doi
5714:109
2264:PMC
2254:doi
2165:WHO
1973:doi
1897:PMC
1889:doi
1444:doi
1377:doi
101:or
88:of
45:or
7493::
7418:.
7410:.
7398:85
7396:.
7392:.
7375:.
7367:.
7357:15
7355:.
5795:^
5769:.
5732:.
5724:.
5712:.
5708:.
5664:.
5631:.
5605:.
5598:.
5572:.
5565:.
5539:.
5532:.
5506:.
5499:.
5473:.
5466:.
5440:.
5433:.
5407:.
5400:.
5370:.
5344:.
5337:.
5311:.
5304:.
5278:.
5271:.
5245:.
5238:.
5227:^
5209:.
5202:.
5169:.
5143:.
5136:.
5110:.
5103:.
5077:.
5070:.
5044:.
5037:.
5011:.
5004:.
4978:.
4971:.
4938:.
4905:.
4872:.
4846:.
4839:.
4806:.
4773:.
4747:.
4740:.
4707:.
4681:.
4674:.
4641:.
4608:.
4575:.
4549:.
4542:.
4516:.
4509:.
4483:.
4476:.
4450:.
4443:.
4417:.
4410:.
4384:.
4377:.
4351:.
4344:.
4318:.
4311:.
4278:.
4245:.
4219:.
4212:.
4186:.
4179:.
4153:.
4146:.
4120:.
4113:.
4087:.
4080:.
4054:.
4047:.
4021:.
4014:.
3988:.
3981:.
3955:.
3948:.
3915:.
3889:.
3882:.
3856:.
3849:.
3823:.
3816:.
3790:.
3783:.
3750:.
3724:.
3717:.
3684:.
3658:.
3651:.
3625:.
3618:.
3607:^
3582:.
3554:.
3528:.
3521:.
3495:.
3488:.
3462:.
3455:.
3429:.
3422:.
3396:.
3389:.
3363:.
3356:.
3330:.
3323:.
3297:.
3290:.
3264:.
3257:.
3231:.
3224:.
3213:^
3188:.
3155:.
3122:.
3089:.
3063:.
3056:.
3023:.
2990:.
2957:.
2924:.
2898:.
2891:.
2858:.
2832:.
2825:.
2799:.
2792:.
2759:.
2726:.
2700:.
2693:.
2660:.
2634:.
2627:.
2601:.
2594:.
2561:.
2535:.
2528:.
2502:.
2495:.
2469:.
2462:.
2429:.
2403:.
2396:.
2370:.
2363:.
2334:.
2330:.
2294:.
2272:.
2262:.
2250:16
2248:.
2244:.
2217:.
2188:.
2163:.
2137:.
2107:.
2077:.
2044:.
2029:^
2011:.
2003:.
1981:.
1969:13
1967:.
1963:.
1934:12
1932:.
1928:.
1905:.
1895:.
1885:75
1883:.
1879:.
1816:.
1805:^
1787:.
1758:.
1750:.
1721:.
1695:.
1618:.
1452:.
1440:18
1438:.
1434:.
1408:.
1383:.
1373:26
1371:.
1359:^
237:,
233:,
131:.
37:A
7469::
7426:.
7404::
7383:.
7363::
7336:.
7306:.
7280:.
7250:.
7220:.
7190:.
7160:.
7130:.
7100:.
7070:.
7040:.
7010:.
6980:.
6950:.
6920:.
6890:.
6860:.
6830:.
6800:.
6770:.
6740:.
6710:.
6680:.
6650:.
6620:.
6590:.
6560:.
6530:.
6500:.
6470:.
6440:.
6410:.
6380:.
6350:.
6320:.
6290:.
6260:.
6230:.
6200:.
6170:.
6140:.
6110:.
6080:.
6050:.
6020:.
5990:.
5960:.
5930:.
5900:.
5870:.
5841:.
5830:.
5789:.
5755:.
5720::
5691:.
5680:.
5650:.
5617:.
5584:.
5551:.
5518:.
5485:.
5452:.
5419:.
5386:.
5356:.
5323:.
5290:.
5257:.
5221:.
5188:.
5155:.
5122:.
5089:.
5056:.
5023:.
4990:.
4957:.
4924:.
4891:.
4858:.
4825:.
4792:.
4759:.
4726:.
4693:.
4660:.
4627:.
4594:.
4561:.
4528:.
4495:.
4462:.
4429:.
4396:.
4363:.
4330:.
4297:.
4264:.
4231:.
4198:.
4165:.
4132:.
4099:.
4066:.
4033:.
4000:.
3967:.
3934:.
3901:.
3868:.
3835:.
3802:.
3769:.
3736:.
3703:.
3670:.
3637:.
3601:.
3568:.
3540:.
3507:.
3474:.
3441:.
3408:.
3375:.
3342:.
3309:.
3276:.
3243:.
3207:.
3174:.
3141:.
3108:.
3075:.
3042:.
3009:.
2976:.
2943:.
2910:.
2877:.
2844:.
2811:.
2778:.
2745:.
2712:.
2679:.
2646:.
2613:.
2580:.
2547:.
2514:.
2481:.
2448:.
2415:.
2382:.
2349:.
2313:.
2280:.
2256::
2229:.
2203:.
2149:.
2123:.
2093:.
2063:.
2023:.
1989:.
1975::
1948:.
1913:.
1891::
1847:.
1836:.
1773:.
1663:.
1637:.
1604:.
1568:.
1532:.
1496:.
1460:.
1446::
1391:.
1379::
34:.
20:)
Text is available under the Creative Commons Attribution-ShareAlike License. Additional terms may apply.