628:(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.
171:
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
263:
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.
286:(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."
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326:(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.
332:: 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.
137:(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.
245:
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
81:
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
210:
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
178:
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
266:
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
258:
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
237:
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
170:
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
262:
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.
253:
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
278:
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
338:: 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.
316:: 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.
211:
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.
624:(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
94:). 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.
294:
Biosimilars available in
Australia include adalimumab, bevacizumab, enoxaparin, epoetin lambda, etanercept, filgrastim, follitropin alfa, infliximab, insulin aspart, insulin glargine, pegfilgrastim, rituximab, teriparatide, and trastuzumab.
42:
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
259:
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.
254:
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
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2001:
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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.
179:
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.
2038:
303:
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.
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101:(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.
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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
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the purpose to verify comparability in pharmacokinetics of the biosimilar with the reference medicinal product in a sufficiently sensitive and homogeneous population.
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type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all
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The FDA gained the authority to approve biosimilars (including interchangeables that are substitutable with their reference product) as part of the
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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
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In the
European Union, no unique identifier of a biosimilar medicine product is required, as the same rules are followed as for all biologics.
1569:
Guidelines on evaluation of monoclonal antibodies (mAbs) as similar biotherapeutic products (SBPs), Annex 2, Technical Report Series No. 1004
347:
Biosimilar medicines approved in the
European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.
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Hearing: Assessing the Impact of a Safe and
Equitable Biosimilar Policy in the United States. Subcommittee on Health Wednesday, May 2, 2007
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Amgevita, Amsparity, Cyltezo, Halimatoz, Hefiya, Hukyndra, Hulio, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma
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inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of
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Cloning of human genetic material and development of in vitro biological production systems has allowed the production of virtually any
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any minor differences (if these exist) between the biosimilar and its reference monoclonal antibody also at the clinical level.
1707:
5960:
5900:
5756:"Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars policy framework"
282:
A version of the four-letter suffix has been proposed to the WHO as the biological qualifier (BQ). It is not part of the
1604:
279:
compromising the INN system and delaying the marketing of biosimilars. Australia decided not to use a 4-letter suffix.
440:
Accofil, Biograstim, Filgrastim Hexal, Filgrastim ratiopharm, Grastofil, Nivestim, Ratiograstim, Tevagrastim, Zarzio
283:
112:
in the EU in 2013. On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of
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74:
5056:
1638:"US Senate Committee on the Judiciary, Testimony of Dr. Lester Crawford, Acting Commissioner, FDA June 23, 2004"
104:
The EMA has granted marketing authorizations for more than 50 biosimilars since 2006. The first biosimilar of a
5650:
1662:
62:, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.
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195:
technology combined with recombinant DNA technology has paved the way for tailor-made and targeted medicines.
5730:
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1497:
Guidelines on evaluation of similar
Biotherapeutic Products (SBPs), Annex 2, Technical Report Series No. 977
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1995:
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625:
323:
134:
70:
4495:
4231:
3736:
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5990:
2172:"WHO Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products"
1733:
6291:"FDA approves first biosimilar to Neulasta to help reduce the risk of infection during cancer treatment"
1693:
7455:
5800:
3342:
1708:"FDA page on "Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting""
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1503:
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98:
66:
1641:
231:
1682:"FDA page on "Follow-On Protein Products: Regulatory and Scientific Issues Related to Developing""
3802:
635:
and transitioning insulin and human growth hormone to regulation as biologics rather than drugs.
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2547:
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1419:
Lamanna WC, Holzmann J, Cohen HP, Guo X, Schweigler M, Stangler T, et al. (April 2018).
242:
20:
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3108:
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2514:
2349:
4198:
3042:
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8:
7379:"Biosimilar epoetins and other "follow-on" biologics: update on the European experiences"
7378:
1990:"Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability"
230:, monoclonal antibodies and more) any other biotech company can develop and market these
192:
105:
2257:
2230:
2229:
Fasseeh AN, Elezbawy B, El-Fass KA, GamaI M, Seyam A, Hayek N, et al. (June 2023).
1915:"Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies"
616:
of 2009 (BPCI Act) was originally sponsored and introduced on June 26, 2007, by
Senator
7408:
7365:
6141:"FDA approves first biosimilar for the treatment of certain breast and stomach cancers"
5722:
1890:
1865:
1373:
47:
expires. Reference to the innovator product is an integral component of the approval.
7412:
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7357:
5714:
2262:
1971:
1895:
1881:
1719:
1442:
393:
255:
160:
59:
39:
7369:
5726:
1377:
147:
The FDA has previously approved biologic products using comparability, for example,
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7349:
5706:
2252:
2242:
1961:
1885:
1877:
1432:
1365:
1097:
1069:
484:
445:
91:
87:
1437:
1420:
7469:
1966:
1949:
1852:
1669:
1356:
Nick, C (2012). "The US Biosimilars Act: Challenges Facing Regulatory Approval".
388:
Abevmy, Alymsys, Aybintio, Equidacent, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev
188:
44:
2247:
1866:"Generics, chemisimilars and biosimilars: is clinical testing fit for purpose?"
1421:"Maintaining consistent quality and clinical performance of biopharmaceuticals"
497:
471:
227:
219:
83:
55:
2314:"EU Approved biosimilars by molecule [data arranged from EMA website]"
7479:
5827:
5677:
1833:
1181:
1153:
1027:
985:
845:
803:
518:
Cegfila, Fulphila, Grasustek, Pelgraz, Pelmeg, Udenyca, Stimufend, Ziextenzo
510:
78:
7444:
7435:
7426:
7307:"FDA Approves Interchangeable Biosimilar for Multiple Inflammatory Diseases"
7404:
7361:
5718:
2266:
2064:"Australian Government Announces Decision on Biosimilar Naming Conventions"
1975:
1899:
1446:
789:
632:
562:
406:
200:
196:
51:
5710:
1279:
1265:
1251:
1237:
1195:
1167:
1139:
1083:
943:
929:
901:
887:
873:
761:
747:
617:
588:
575:
523:
380:
223:
7353:
6231:"FDA approves first epoetin alfa biosimilar for the treatment of anemia"
1950:"Biosimilar monoclonal antibodies: a science-based regulatory challenge"
5692:"Biosimilars: the need, the challenge, the future: the FDA perspective"
1803:"Statement on low-cost biosimilar and interchangeable protein products"
1392:"Biosimilars in the EU: Information guide for healthcare professionals"
1369:
1293:
1223:
1209:
1125:
1111:
1041:
1013:
999:
971:
915:
831:
817:
775:
733:
719:
705:
691:
677:
663:
549:
458:
432:
419:
367:
156:
152:
113:
109:
7395:
7340:
Udpa N, Million RP (January 2016). "Monoclonal antibody biosimilars".
1321:
1307:
1055:
957:
859:
536:
148:
2028:"The International Debate on Generic Medicines of Biological Origin"
214:
After the expiry of the patent of approved recombinant drugs (e.g.,
5795:
5793:
5791:
5789:
5787:
5785:
544:
Blitzima, Ritemvia, Rituzena, Rixathon, Riximyo, Ruxience, Truxima
207:
1461:
Guidelines on evaluation of similar Biotherapeutic Products (SBPs)
5826:
This article incorporates text from this source, which is in the
5676:
This article incorporates text from this source, which is in the
1832:
This article incorporates text from this source, which is in the
215:
5782:
191:
based biological substance for eventual development of a drug.
172:
167:
117:
1734:"FDA Response to three Citizen Petitions against biosimilars"
1774:"FDA page on "FDA approves first biosimilar product Zarxio""
6081:"FDA approves first biosimilar for the treatment of cancer"
2228:
1533:
WHO Questions and Answers: Similar Biotherapeutic Products
596:
Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac
5689:
414:
Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo
5690:
Epstein MS, Ehrenpreis ED, Kulkarni PM (December 2014).
2204:"Which biosimilar medicines are available in Australia?"
2124:"Which biosimilar medicines are available in Australia?"
2231:"Maximizing the benefits of using biosimilars in Egypt"
1846:
EMEA guideline on similar biological medicinal products
1418:
479:
Fiasp, Insulin aspart Sanofi, Kirsty, NovoMix, Ryzodeg
6261:"Drug Approval Package: Retacrit (epoetin alfa-epbx )"
144:
signed into law by President Obama on March 23, 2010.
7453:
6531:"Drug Approval Package: Trazimera (trastuzumab-qyyp)"
6501:"Drug Approval Package: Ontruzant (trastuzumab-dttb)"
4562:"Cegfila (previously Pegfilgrastim Mundipharma) EPAR"
1399:
European Medicines Agency and the European Commission
6021:"Drug Approval Package: Renflexis (infliximab-abda)"
6351:"Drug Approval Package: Nivestym (filgrastim-aafi)"
5991:"Drug Approval Package: Amjevita (adalimumab-atto)"
6171:"Drug Approval Package: Ogivri (Trastuzumab-dkst)"
5219:
5217:
6441:"Drug Approval Package: Truxima (rituximab-abbs)"
6111:"Drug Approval Package: Mvasi (bevacizumab-awwb)"
5931:"Drug Approval Package: Erelzi (etanercept-szzs)"
1351:
1349:
241:The current concept of development of biosimilar
7477:
6201:"Drug Approval Package: Ixifi (infliximab-qbtx)"
3599:
3597:
1797:
1795:
5961:"FDA approves Amjevita, a biosimilar to Humira"
5214:
4884:
308:Key Findings and Recommendations of the article
69:(EMA) of the European Union, the United States
5148:
5082:
5049:
5016:
4983:
4950:
4818:
3236:
3205:
3203:
1346:
614:Biologics Price Competition and Innovation Act
116:called filgrastim-sndz (trade name Zarxio) by
5901:"FDA approves Erelzi, a biosimilar to Enbrel"
5181:
5115:
4917:
4851:
3594:
3134:
2738:
2540:
2235:Journal of Pharmaceutical Policy and Practice
2116:
1792:
322:: A significant emphasis was placed on using
108:to be approved worldwide was a biosimilar of
3561:
1941:
7339:
5871:"Inflectra (infliximab-dyyb) for Injection"
4257:
3200:
7436:Biosimilar Regulatory Review and Approval
7221:"Drug Approval Package: Yuflyma injection"
2281:"Biosimilar medicines can be interchanged"
1597:
638:
622:Patient Protection and Affordable Care Act
203:therapies are emerging as new approaches.
142:Patient Protection and Affordable Care Act
7394:
2256:
2246:
2025:
1965:
1889:
1436:
620:(D-MA). It was formally passed under the
7376:
5699:The American Journal of Gastroenterology
1947:
1870:British Journal of Clinical Pharmacology
7111:from the original on September 29, 2022
6271:from the original on September 27, 2021
4872:from the original on September 10, 2021
4839:from the original on September 10, 2021
4278:from the original on September 15, 2021
4179:from the original on September 22, 2023
3981:from the original on September 23, 2020
2330:from the original on September 19, 2020
2306:
2294:from the original on September 20, 2022
1355:
7478:
7317:from the original on November 13, 2023
7261:from the original on November 26, 2023
7201:from the original on February 10, 2023
7081:from the original on September 3, 2022
6691:from the original on December 18, 2019
6661:from the original on December 18, 2019
6631:from the original on December 18, 2019
6601:from the original on December 18, 2019
6571:from the original on December 18, 2019
6541:from the original on December 18, 2019
6511:from the original on December 18, 2019
6481:from the original on December 18, 2019
6451:from the original on December 18, 2019
6421:from the original on December 18, 2019
6391:from the original on December 18, 2019
6361:from the original on December 20, 2019
6211:from the original on December 18, 2019
6151:from the original on December 15, 2019
6121:from the original on February 23, 2023
6061:from the original on February 18, 2020
6031:from the original on December 18, 2019
5971:from the original on November 19, 2019
5851:from the original on December 20, 2019
5367:from the original on December 18, 2021
5202:from the original on September 9, 2021
5169:from the original on September 9, 2021
5136:from the original on September 9, 2021
5103:from the original on September 9, 2021
5070:from the original on September 9, 2021
5037:from the original on September 9, 2021
5004:from the original on September 9, 2021
4971:from the original on September 9, 2021
4674:from the original on December 30, 2019
4509:from the original on February 24, 2020
4476:from the original on February 24, 2020
4443:from the original on February 15, 2022
4146:from the original on December 30, 2019
4113:from the original on December 29, 2019
3783:from the original on November 12, 2020
3717:from the original on December 30, 2019
3618:from the original on December 20, 2019
3521:from the original on December 30, 2019
3488:from the original on December 30, 2019
3455:from the original on November 12, 2020
3389:from the original on December 30, 2019
3356:from the original on December 30, 2019
3323:from the original on December 30, 2019
3257:from the original on December 30, 2019
3188:from the original on December 30, 2019
3056:from the original on December 30, 2019
2990:from the original on December 29, 2020
2825:from the original on February 18, 2020
2726:from the original on December 30, 2019
2660:from the original on December 30, 2019
2627:from the original on November 16, 2019
2495:from the original on December 30, 2019
2429:from the original on February 18, 2020
2396:from the original on December 30, 2019
2363:from the original on February 18, 2020
2210:from the original on December 30, 2021
2130:from the original on December 30, 2021
2104:from the original on December 30, 2021
2098:Therapeutic Goods Administration (TGA)
2074:from the original on December 30, 2021
2004:from the original on September 6, 2019
1863:
1817:from the original on December 18, 2019
7141:from the original on January 26, 2023
6931:from the original on January 25, 2023
6841:from the original on November 6, 2021
6811:from the original on January 25, 2021
6781:from the original on November 1, 2020
6091:from the original on November 5, 2021
6051:"Cyltezo: FDA Approved Drug Products"
5941:from the original on December 5, 2022
5499:from the original on October 31, 2020
5466:from the original on November 8, 2020
4080:from the original on October 16, 2019
4047:from the original on October 16, 2019
4014:from the original on October 22, 2020
3948:from the original on October 28, 2020
3882:from the original on October 15, 2019
3849:from the original on October 16, 2019
3750:from the original on January 21, 2021
3684:from the original on October 22, 2020
3422:from the original on October 22, 2020
3224:from the original on October 29, 2020
3155:from the original on January 28, 2023
3089:from the original on November 5, 2021
3023:from the original on October 13, 2020
2528:from the original on October 15, 2019
2290:(Press release). September 19, 2022.
2184:from the original on October 31, 2017
2021:
2019:
1929:from the original on January 19, 2021
123:
65:Drug-related authorities such as the
7445:Interchangeable Biological Products
7231:from the original on August 25, 2023
7171:from the original on August 25, 2023
6871:from the original on August 28, 2021
6751:from the original on October 4, 2020
6241:from the original on August 28, 2021
6001:from the original on October 4, 2020
5911:from the original on August 28, 2021
5811:from the original on August 28, 2021
5766:(Press release). December 11, 2018.
5661:from the original on August 28, 2021
5400:from the original on October 5, 2023
5337:from the original on August 14, 2019
4905:from the original on October 6, 2022
4344:from the original on August 28, 2021
4212:from the original on August 28, 2021
3816:from the original on August 14, 2020
3122:from the original on October 8, 2021
2957:from the original on October 8, 2021
2924:from the original on August 28, 2021
2858:from the original on August 28, 2021
1954:Expert Opinion on Biological Therapy
1912:
1425:Expert Opinion on Biological Therapy
466:Flixabi, Inflectra, Remsima, Zessly
351:European Union approved biosimilars
336:Post-Marketing and Pharmacovigilance
6181:from the original on March 22, 2023
5565:from the original on August 4, 2020
5532:from the original on March 24, 2020
4938:from the original on March 13, 2023
4773:from the original on April 21, 2022
4377:from the original on August 4, 2020
4311:from the original on April 13, 2020
3651:from the original on March 23, 2020
3290:from the original on March 23, 2020
2891:from the original on March 18, 2020
2759:from the original on April 24, 2022
2693:from the original on March 24, 2020
2594:from the original on March 24, 2020
2561:from the original on April 24, 2022
2462:from the original on August 6, 2020
1618:from the original on March 29, 2020
1585:from the original on April 14, 2021
1549:from the original on April 21, 2019
427:Benepali, Erelzi, Lifmior, Nepexto
13:
7333:
7281:"Drug Approval Package: Tofidence"
7131:"Drug Approval Package: Stimufend"
6951:"Drug Approval Package: Rezvoglar"
6721:from the original on June 11, 2020
6711:"Drug Approval Package: Ziextenzo"
6331:from the original on June 11, 2020
6301:from the original on June 11, 2020
5631:from the original on July 28, 2020
5598:from the original on July 28, 2020
5433:from the original on July 28, 2020
5271:from the original on June 27, 2020
5238:from the original on July 27, 2020
4806:from the original on June 11, 2020
4740:from the original on June 11, 2020
4707:from the original on June 11, 2020
4641:from the original on June 11, 2020
4608:from the original on June 11, 2020
4575:from the original on June 11, 2020
4542:from the original on June 11, 2020
4410:from the original on April 2, 2022
4245:from the original on July 17, 2020
2792:from the original on June 25, 2019
2044:from the original on March 6, 2021
2016:
602:
14:
7502:
7420:
7161:"Drug Approval Package: Vegzelma"
7071:"Drug Approval Package: Fylnetra"
7051:from the original on May 27, 2022
7021:from the original on May 27, 2022
6991:from the original on May 27, 2022
6961:from the original on May 27, 2022
6901:from the original on May 27, 2022
6801:"Drug Approval Package: Nyvepria"
6741:"Drug Approval Package: Abrilada"
6651:"Drug Approval Package: Ruxience"
6591:"Drug Approval Package: Kanjinti"
6321:"Drug Approval Package: Fulphila"
5881:from the original on May 20, 2022
5655:U.S. Food and Drug Administration
3915:from the original on July 1, 2020
3582:from the original on June 4, 2020
2094:"Biosimilar medicines regulation"
1754:from the original on May 31, 2017
1513:from the original on May 30, 2015
342:
284:international nonproprietary name
155:was also to a reference product,
7463:
7299:
7273:
7243:
7213:
7183:
7153:
7123:
7101:"Drug Approval Package: Cimerli"
7093:
7063:
7041:"Drug Approval Package: Alymsys"
7033:
7011:"Drug Approval Package: Releuko"
7003:
6981:"Drug Approval Package: Yusimry"
6973:
6943:
6921:"Drug Approval Package: Byooviz"
6913:
6891:"Drug Approval Package: Semglee"
6883:
6853:
6823:
6793:
6763:
6733:
6703:
6681:"Drug Approval Package: Hadlima"
6673:
6643:
6621:"Drug Approval Package: Zirabev"
6613:
6583:
6561:"Drug Approval Package: Eticovo"
6553:
6523:
6493:
6471:"Drug Approval Package: Herzuma"
6463:
6433:
6411:"Drug Approval Package: Udenyca"
6403:
6381:"Drug Approval Package: Hyrimoz"
6373:
6343:
6313:
6283:
6253:
6223:
6193:
6163:
6133:
6103:
6073:
6043:
6013:
5983:
5953:
5923:
5893:
5863:
5833:
5821:
5770:from the original on May 8, 2019
5748:
5683:
5671:
5643:
5610:
5577:
5544:
5511:
5478:
5445:
5412:
5379:
5349:
5316:
5304:from the original on May 1, 2022
5283:
5250:
4785:
4752:
4719:
4686:
4653:
4620:
4587:
1882:10.1111/j.1365-2125.2012.04323.x
1827:
1605:"Biosimilar medicines: Overview"
128:
7427:Overview of Biosimilar Products
7251:"Drug Approval Package: Tyruko"
7191:"Drug Approval Package: Idacio"
6861:"Drug Approval Package: Riabni"
6771:"Drug Approval Package: Avsola"
4554:
4521:
4488:
4455:
4422:
4389:
4356:
4323:
4290:
4224:
4191:
4158:
4125:
4092:
4059:
4026:
3993:
3960:
3927:
3894:
3861:
3828:
3795:
3762:
3729:
3696:
3663:
3630:
3533:
3500:
3467:
3434:
3401:
3368:
3335:
3302:
3269:
3167:
3101:
3068:
3035:
3002:
2969:
2936:
2903:
2870:
2837:
2804:
2771:
2705:
2672:
2639:
2606:
2573:
2507:
2474:
2441:
2408:
2375:
2342:
2273:
2222:
2196:
2164:
2142:
2086:
2056:
1982:
1906:
1857:
1839:
1766:
1726:
1700:
1674:
1656:
1630:
1094:insulin glargine-aglr/Rezvoglar
646:Date of Biosimilar FDA Approval
270:
75:Health Products and Food Branch
7383:American Journal of Hematology
7342:Nature Reviews. Drug Discovery
6831:"Drug Approval Package: Hulio"
1561:
1525:
1489:
1453:
1412:
1384:
1337:
16:Variant of a biopharmaceutical
1:
5801:"Biosimilar Drug Information"
1948:Declerck PJ (February 2013).
1438:10.1080/14712598.2018.1421169
1330:
1066:insulin glargine-yfgn/Semglee
182:
7449:Food and Drug Administration
7440:Food and Drug Administration
7431:Food and Drug Administration
7311:Food and Drug Administration
7285:Food and Drug Administration
7255:Food and Drug Administration
7225:Food and Drug Administration
7195:Food and Drug Administration
7165:Food and Drug Administration
7135:Food and Drug Administration
7105:Food and Drug Administration
7075:Food and Drug Administration
7045:Food and Drug Administration
7015:Food and Drug Administration
6985:Food and Drug Administration
6955:Food and Drug Administration
6925:Food and Drug Administration
6895:Food and Drug Administration
6865:Food and Drug Administration
6835:Food and Drug Administration
6805:Food and Drug Administration
6775:Food and Drug Administration
6745:Food and Drug Administration
6715:Food and Drug Administration
6685:Food and Drug Administration
6655:Food and Drug Administration
6625:Food and Drug Administration
6595:Food and Drug Administration
6565:Food and Drug Administration
6535:Food and Drug Administration
6505:Food and Drug Administration
6475:Food and Drug Administration
6445:Food and Drug Administration
6415:Food and Drug Administration
6385:Food and Drug Administration
6355:Food and Drug Administration
6325:Food and Drug Administration
6295:Food and Drug Administration
6265:Food and Drug Administration
6235:Food and Drug Administration
6205:Food and Drug Administration
6175:Food and Drug Administration
6145:Food and Drug Administration
6115:Food and Drug Administration
6085:Food and Drug Administration
6055:Food and Drug Administration
6025:Food and Drug Administration
5995:Food and Drug Administration
5965:Food and Drug Administration
5935:Food and Drug Administration
5905:Food and Drug Administration
5875:Food and Drug Administration
5845:Food and Drug Administration
5805:Food and Drug Administration
5762:Food and Drug Administration
4496:"Insulin lispro Sanofi EPAR"
4232:"Insulin aspart Sanofi EPAR"
3737:"Filgrastim ratiopharm EPAR"
1996:Food and Drug Administration
1967:10.1517/14712598.2012.758710
1809:Food and Drug Administration
1780:Food and Drug Administration
1743:Food and Drug Administration
1714:Food and Drug Administration
1688:Food and Drug Administration
1178:pegfilgrastim-fpgk/Stimufend
982:pegfilgrastim-bmez/Ziextenzo
626:Food and Drug Administration
531:Byooviz, Ranivisio, Ximluci
324:Health Technology Assessment
289:
135:Food and Drug Administration
71:Food and Drug Administration
7:
7377:Jelkmann W (October 2010).
2026:Velásquez G (August 2018).
1668:September 22, 2007, at the
1470:(WHO). 2009. Archived from
1150:pegfilgrastim-pbbk/Fylnetra
1024:pegfilgrastim-apgf/Nyvepria
800:pegfilgrastim-jmdb/Fulphila
607:
234:(thus called biosimilars).
175:is biosimilar to Neupogen.
159:, originally approved as a
151:in May 2006, but this like
10:
7507:
7167:(FDA). December 13, 2022.
7137:(FDA). November 16, 2022.
6897:(FDA). September 2, 2021.
6717:(FDA). December 27, 2019.
6687:(FDA). September 5, 2019.
6447:(FDA). February 25, 2019.
6357:(FDA). February 21, 2019.
6267:(FDA). December 13, 2018.
6207:(FDA). November 29, 2018.
6177:(FDA). November 29, 2018.
6027:(FDA). December 10, 2018.
5841:"Zarxio (filgrastim-sndz)"
2248:10.1186/s40545-023-00581-w
2068:The Center For Biosimilars
1864:Warren JB (January 2013).
1248:tocilizumab-bavi/Tofidence
898:trastuzumab-qyyp/Trazimera
884:trastuzumab-dttb/Ontruzant
842:pegfilgrastim-cbqv/Udenyca
786:epoetin alfa-epbx/Retacrit
133:In the United States, the
18:
7313:(FDA). October 31, 2023.
7257:(FDA). October 11, 2023.
7197:(FDA). February 9, 2023.
6987:(FDA). January 18, 2021.
6957:(FDA). January 28, 2022.
6867:(FDA). January 26, 2021.
6777:(FDA). January 30, 2020.
6747:(FDA). January 28, 2020.
6477:(FDA). February 7, 2019.
6327:(FDA). October 26, 2018.
6117:(FDA). October 10, 2018.
5997:(FDA). November 9, 2016.
5937:(FDA). October 25, 2016.
5623:European Medicines Agency
5590:European Medicines Agency
5557:European Medicines Agency
5524:European Medicines Agency
5491:European Medicines Agency
5458:European Medicines Agency
5425:European Medicines Agency
5392:European Medicines Agency
5361:European Medicines Agency
5329:European Medicines Agency
5296:European Medicines Agency
5263:European Medicines Agency
5230:European Medicines Agency
5194:European Medicines Agency
5161:European Medicines Agency
5128:European Medicines Agency
5095:European Medicines Agency
5062:European Medicines Agency
5029:European Medicines Agency
4996:European Medicines Agency
4963:European Medicines Agency
4930:European Medicines Agency
4897:European Medicines Agency
4864:European Medicines Agency
4831:European Medicines Agency
4798:European Medicines Agency
4765:European Medicines Agency
4732:European Medicines Agency
4699:European Medicines Agency
4666:European Medicines Agency
4633:European Medicines Agency
4600:European Medicines Agency
4567:European Medicines Agency
4534:European Medicines Agency
4501:European Medicines Agency
4468:European Medicines Agency
4435:European Medicines Agency
4402:European Medicines Agency
4369:European Medicines Agency
4336:European Medicines Agency
4303:European Medicines Agency
4270:European Medicines Agency
4237:European Medicines Agency
4204:European Medicines Agency
4171:European Medicines Agency
4138:European Medicines Agency
4105:European Medicines Agency
4072:European Medicines Agency
4039:European Medicines Agency
4006:European Medicines Agency
3973:European Medicines Agency
3940:European Medicines Agency
3907:European Medicines Agency
3874:European Medicines Agency
3841:European Medicines Agency
3808:European Medicines Agency
3775:European Medicines Agency
3742:European Medicines Agency
3709:European Medicines Agency
3676:European Medicines Agency
3643:European Medicines Agency
3610:European Medicines Agency
3574:European Medicines Agency
3546:European Medicines Agency
3513:European Medicines Agency
3480:European Medicines Agency
3447:European Medicines Agency
3414:European Medicines Agency
3381:European Medicines Agency
3348:European Medicines Agency
3343:"Epoetin Alfa Hexal EPAR"
3315:European Medicines Agency
3282:European Medicines Agency
3249:European Medicines Agency
3216:European Medicines Agency
3180:European Medicines Agency
3147:European Medicines Agency
3114:European Medicines Agency
3081:European Medicines Agency
3048:European Medicines Agency
3015:European Medicines Agency
2982:European Medicines Agency
2949:European Medicines Agency
2916:European Medicines Agency
2883:European Medicines Agency
2850:European Medicines Agency
2817:European Medicines Agency
2784:European Medicines Agency
2751:European Medicines Agency
2718:European Medicines Agency
2685:European Medicines Agency
2652:European Medicines Agency
2619:European Medicines Agency
2586:European Medicines Agency
2553:European Medicines Agency
2520:European Medicines Agency
2487:European Medicines Agency
2454:European Medicines Agency
2421:European Medicines Agency
2388:European Medicines Agency
2355:European Medicines Agency
2286:European Medicines Agency
2035:South Centre Policy Brief
1610:European Medicines Agency
1576:World Health Organization
1540:World Health Organization
1504:World Health Organization
1468:World Health Organization
1192:bevacizumab-adcd/Vegzelma
926:trastuzumab-anns/Kanjinti
716:infliximab-abda/Renflexis
674:infliximab-dyyb/Inflectra
238:was approved by the EMA.
99:World Health Organization
67:European Medicines Agency
36:subsequent entry biologic
7227:(FDA). August 11, 2023.
7107:(FDA). August 23, 2022.
6927:(FDA). October 1, 2021.
6837:(FDA). October 2, 2020.
6807:(FDA). August 11, 2020.
6627:(FDA). August 14, 2019.
1919:BioProcess International
1290:adalimumab-ryvk/Simlandi
1262:ustekinumab-auub/Wezlana
1164:ranibizumab-eqrn/Cimerli
1136:bevacizumab-maly/Alymsys
1080:ranibizumab-nuna/Byooviz
996:adalimumab-afzb/Abrilada
940:bevacizumab-bvzr/Zirabev
870:trastuzumab-pkrb/Herzuma
814:filgrastim-aafi/Nivestym
702:adalimumab-atto/Amjevita
298:
206:Recombinant therapeutic
163:under the FD&C Act.
40:biologic medical product
7287:(FDA). November 7, 2023
7017:(FDA). April 11, 2022.
6657:(FDA). August 9, 2019.
6387:(FDA). March 21, 2019.
5847:(FDA). April 20, 2015.
3704:"Filgrastim Hexal EPAR"
1913:Wang X (June 1, 2014).
1304:denosumab-bbdz/Jubbonti
1276:bevacizumab-tnjn/Avzivi
1234:natalizumab-sztn/Tyruko
1220:adalimumab-aaty/Yuflyma
1122:filgrastim-ayow/Releuko
1108:adalimumab-aqvh/Yusimry
968:adalimumab-bwwd/Hadlima
954:rituximab-pvvr/Ruxience
912:etanercept-ykro/Eticovo
828:adalimumab-adaz/Hyrimoz
758:trastuzumab-dkst/Ogivri
730:adalimumab-adbm/Cyltezo
639:US approved biosimilars
7491:Life sciences industry
7309:(Press release). U.S.
7077:(FDA). July 15, 2022.
6597:(FDA). July 18, 2019.
6567:(FDA). June 18, 2019.
6507:(FDA). March 5, 2019.
6417:(FDA). March 5, 2019.
6293:(Press release). U.S.
6233:(Press release). U.S.
6143:(Press release). U.S.
6083:(Press release). U.S.
5963:(Press release). U.S.
5903:(Press release). U.S.
5877:(FDA). June 27, 2016.
4934:. September 14, 2022.
4802:. September 24, 2018.
4703:. September 24, 2018.
4604:. September 24, 2018.
3746:. September 17, 2018.
3680:. September 17, 2018.
2755:. September 14, 2021.
2557:. September 14, 2021.
2150:"Biological Qualifier"
1851:June 30, 2007, at the
1614:. September 17, 2018.
1401:. 2017. Archived from
1206:adalimumab-aacf/Idacio
1010:infliximab-axxq/Avsola
856:rituximab-abbs/Truxima
744:bevacizumab-awwb/Mvasi
688:etanercept-szzs/Erelzi
660:filgrastim-sndz/Zarxio
505:Insulin lispro Sanofi
7047:(FDA). May 11, 2022.
6537:(FDA). May 17, 2019.
3184:. December 11, 2018.
2920:. February 24, 2021.
2321:Biosimilars Nederland
1813:. December 17, 2019.
1477:on September 29, 2021
1052:rituximab-arrx/Riabni
1038:adalimumab-fkjp/Hulio
772:infliximab-qbtx/Ixifi
362:Biosimilar medicines
243:monoclonal antibodies
21:Biosimilars (journal)
19:For the journal, see
5711:10.1038/ajg.2014.151
5363:. January 16, 2009.
5165:. January 29, 2020.
4769:. January 24, 2022.
4571:. October 16, 2019.
4274:. December 9, 2020.
3911:. October 20, 1995.
3118:. January 25, 2021.
3085:. November 9, 2020.
2953:. January 25, 2021.
2854:. December 9, 2020.
2722:. January 29, 2019.
2656:. January 29, 2019.
2425:. December 9, 2019.
2070:. January 31, 2018.
1644:on December 28, 2016
1408:on October 15, 2019.
1318:denosumab-bbdz/Wyost
7354:10.1038/nrd.2015.12
3803:"Ratiograstim EPAR"
1722:on October 7, 2010.
492:Abasaglar, Semglee
352:
193:Monoclonal antibody
106:monoclonal antibody
54:of the more common
7486:Biopharmaceuticals
5736:on October 6, 2016
4637:. April 24, 2019.
4241:. April 28, 2020.
3836:"Tevagrastim EPAR"
3578:. March 24, 2020.
2160:on March 28, 2015.
1370:10.1007/bf03262388
649:Biosimilar Product
401:Inhixa, Thorinane
350:
166:On March 6, 2015,
124:Approval processes
60:biopharmaceuticals
32:follow-on biologic
7396:10.1002/ajh.21805
5657:. July 27, 2021.
4901:. June 20, 2022.
4868:. June 23, 2021.
3671:"Biograstim EPAR"
3151:. June 20, 2022.
3019:. July 20, 2020.
3010:"Equidacent EPAR"
2100:. April 4, 2018.
1788:on March 7, 2015.
1328:
1327:
652:Original Product
600:
599:
570:Movymia, Terrosa
453:Bemfola, Ovaleap
394:Enoxaparin sodium
359:Reference product
256:pharmacovigilance
7498:
7468:
7467:
7466:
7459:
7416:
7398:
7373:
7327:
7326:
7324:
7322:
7303:
7297:
7296:
7294:
7292:
7277:
7271:
7270:
7268:
7266:
7247:
7241:
7240:
7238:
7236:
7217:
7211:
7210:
7208:
7206:
7187:
7181:
7180:
7178:
7176:
7157:
7151:
7150:
7148:
7146:
7127:
7121:
7120:
7118:
7116:
7097:
7091:
7090:
7088:
7086:
7067:
7061:
7060:
7058:
7056:
7037:
7031:
7030:
7028:
7026:
7007:
7001:
7000:
6998:
6996:
6977:
6971:
6970:
6968:
6966:
6947:
6941:
6940:
6938:
6936:
6917:
6911:
6910:
6908:
6906:
6887:
6881:
6880:
6878:
6876:
6857:
6851:
6850:
6848:
6846:
6827:
6821:
6820:
6818:
6816:
6797:
6791:
6790:
6788:
6786:
6767:
6761:
6760:
6758:
6756:
6737:
6731:
6730:
6728:
6726:
6707:
6701:
6700:
6698:
6696:
6677:
6671:
6670:
6668:
6666:
6647:
6641:
6640:
6638:
6636:
6617:
6611:
6610:
6608:
6606:
6587:
6581:
6580:
6578:
6576:
6557:
6551:
6550:
6548:
6546:
6527:
6521:
6520:
6518:
6516:
6497:
6491:
6490:
6488:
6486:
6467:
6461:
6460:
6458:
6456:
6437:
6431:
6430:
6428:
6426:
6407:
6401:
6400:
6398:
6396:
6377:
6371:
6370:
6368:
6366:
6347:
6341:
6340:
6338:
6336:
6317:
6311:
6310:
6308:
6306:
6287:
6281:
6280:
6278:
6276:
6257:
6251:
6250:
6248:
6246:
6227:
6221:
6220:
6218:
6216:
6197:
6191:
6190:
6188:
6186:
6167:
6161:
6160:
6158:
6156:
6137:
6131:
6130:
6128:
6126:
6107:
6101:
6100:
6098:
6096:
6077:
6071:
6070:
6068:
6066:
6047:
6041:
6040:
6038:
6036:
6017:
6011:
6010:
6008:
6006:
5987:
5981:
5980:
5978:
5976:
5957:
5951:
5950:
5948:
5946:
5927:
5921:
5920:
5918:
5916:
5897:
5891:
5890:
5888:
5886:
5867:
5861:
5860:
5858:
5856:
5837:
5831:
5825:
5824:
5820:
5818:
5816:
5797:
5780:
5779:
5777:
5775:
5752:
5746:
5745:
5743:
5741:
5735:
5729:. Archived from
5696:
5687:
5681:
5675:
5674:
5670:
5668:
5666:
5647:
5641:
5640:
5638:
5636:
5627:. May 26, 2020.
5614:
5608:
5607:
5605:
5603:
5585:"Trazimera EPAR"
5581:
5575:
5574:
5572:
5570:
5552:"Ontruzant EPAR"
5548:
5542:
5541:
5539:
5537:
5515:
5509:
5508:
5506:
5504:
5482:
5476:
5475:
5473:
5471:
5449:
5443:
5442:
5440:
5438:
5420:"Herceptin EPAR"
5416:
5410:
5409:
5407:
5405:
5383:
5377:
5376:
5374:
5372:
5357:"RoActemra EPAR"
5353:
5347:
5346:
5344:
5342:
5320:
5314:
5313:
5311:
5309:
5287:
5281:
5280:
5278:
5276:
5254:
5248:
5247:
5245:
5243:
5225:"Omnitrope EPAR"
5221:
5212:
5211:
5209:
5207:
5185:
5179:
5178:
5176:
5174:
5152:
5146:
5145:
5143:
5141:
5119:
5113:
5112:
5110:
5108:
5086:
5080:
5079:
5077:
5075:
5053:
5047:
5046:
5044:
5042:
5020:
5014:
5013:
5011:
5009:
4987:
4981:
4980:
4978:
4976:
4954:
4948:
4947:
4945:
4943:
4921:
4915:
4914:
4912:
4910:
4892:"Ranivisio EPAR"
4888:
4882:
4881:
4879:
4877:
4855:
4849:
4848:
4846:
4844:
4822:
4816:
4815:
4813:
4811:
4793:"Ziextenzo EPAR"
4789:
4783:
4782:
4780:
4778:
4760:"Stimufend EPAR"
4756:
4750:
4749:
4747:
4745:
4723:
4717:
4716:
4714:
4712:
4690:
4684:
4683:
4681:
4679:
4657:
4651:
4650:
4648:
4646:
4628:"Grasustek EPAR"
4624:
4618:
4617:
4615:
4613:
4591:
4585:
4584:
4582:
4580:
4558:
4552:
4551:
4549:
4547:
4525:
4519:
4518:
4516:
4514:
4492:
4486:
4485:
4483:
4481:
4459:
4453:
4452:
4450:
4448:
4426:
4420:
4419:
4417:
4415:
4397:"Abasaglar EPAR"
4393:
4387:
4386:
4384:
4382:
4360:
4354:
4353:
4351:
4349:
4327:
4321:
4320:
4318:
4316:
4294:
4288:
4287:
4285:
4283:
4261:
4255:
4254:
4252:
4250:
4228:
4222:
4221:
4219:
4217:
4195:
4189:
4188:
4186:
4184:
4166:"NovoRapid EPAR"
4162:
4156:
4155:
4153:
4151:
4129:
4123:
4122:
4120:
4118:
4096:
4090:
4089:
4087:
4085:
4067:"Inflectra EPAR"
4063:
4057:
4056:
4054:
4052:
4030:
4024:
4023:
4021:
4019:
3997:
3991:
3990:
3988:
3986:
3964:
3958:
3957:
3955:
3953:
3931:
3925:
3924:
3922:
3920:
3898:
3892:
3891:
3889:
3887:
3865:
3859:
3858:
3856:
3854:
3832:
3826:
3825:
3823:
3821:
3799:
3793:
3792:
3790:
3788:
3770:"Grastofil EPAR"
3766:
3760:
3759:
3757:
3755:
3733:
3727:
3726:
3724:
3722:
3700:
3694:
3693:
3691:
3689:
3667:
3661:
3660:
3658:
3656:
3634:
3628:
3627:
3625:
3623:
3601:
3592:
3591:
3589:
3587:
3565:
3559:
3558:
3556:
3554:
3537:
3531:
3530:
3528:
3526:
3504:
3498:
3497:
3495:
3493:
3471:
3465:
3464:
3462:
3460:
3438:
3432:
3431:
3429:
3427:
3405:
3399:
3398:
3396:
3394:
3372:
3366:
3365:
3363:
3361:
3339:
3333:
3332:
3330:
3328:
3306:
3300:
3299:
3297:
3295:
3273:
3267:
3266:
3264:
3262:
3244:"Thorinane EPAR"
3240:
3234:
3233:
3231:
3229:
3207:
3198:
3197:
3195:
3193:
3171:
3165:
3164:
3162:
3160:
3138:
3132:
3131:
3129:
3127:
3105:
3099:
3098:
3096:
3094:
3072:
3066:
3065:
3063:
3061:
3039:
3033:
3032:
3030:
3028:
3006:
3000:
2999:
2997:
2995:
2986:. May 26, 2020.
2973:
2967:
2966:
2964:
2962:
2940:
2934:
2933:
2931:
2929:
2907:
2901:
2900:
2898:
2896:
2874:
2868:
2867:
2865:
2863:
2841:
2835:
2834:
2832:
2830:
2808:
2802:
2801:
2799:
2797:
2775:
2769:
2768:
2766:
2764:
2742:
2736:
2735:
2733:
2731:
2709:
2703:
2702:
2700:
2698:
2676:
2670:
2669:
2667:
2665:
2643:
2637:
2636:
2634:
2632:
2610:
2604:
2603:
2601:
2599:
2577:
2571:
2570:
2568:
2566:
2544:
2538:
2537:
2535:
2533:
2511:
2505:
2504:
2502:
2500:
2482:"Halimatoz EPAR"
2478:
2472:
2471:
2469:
2467:
2445:
2439:
2438:
2436:
2434:
2416:"Amsparity EPAR"
2412:
2406:
2405:
2403:
2401:
2379:
2373:
2372:
2370:
2368:
2346:
2340:
2339:
2337:
2335:
2329:
2318:
2310:
2304:
2303:
2301:
2299:
2277:
2271:
2270:
2260:
2250:
2226:
2220:
2219:
2217:
2215:
2200:
2194:
2193:
2191:
2189:
2183:
2176:
2168:
2162:
2161:
2156:. Archived from
2146:
2140:
2139:
2137:
2135:
2120:
2114:
2113:
2111:
2109:
2090:
2084:
2083:
2081:
2079:
2060:
2054:
2053:
2051:
2049:
2043:
2032:
2023:
2014:
2013:
2011:
2009:
1986:
1980:
1979:
1969:
1945:
1939:
1938:
1936:
1934:
1910:
1904:
1903:
1893:
1861:
1855:
1843:
1837:
1831:
1830:
1826:
1824:
1822:
1799:
1790:
1789:
1784:. Archived from
1770:
1764:
1763:
1761:
1759:
1753:
1738:
1730:
1724:
1723:
1718:. Archived from
1704:
1698:
1697:
1696:on July 9, 2009.
1692:. Archived from
1678:
1672:
1660:
1654:
1653:
1651:
1649:
1640:. Archived from
1634:
1628:
1627:
1625:
1623:
1601:
1595:
1594:
1592:
1590:
1584:
1573:
1565:
1559:
1558:
1556:
1554:
1548:
1537:
1529:
1523:
1522:
1520:
1518:
1512:
1501:
1493:
1487:
1486:
1484:
1482:
1476:
1465:
1457:
1451:
1450:
1440:
1416:
1410:
1409:
1407:
1396:
1388:
1382:
1381:
1353:
1344:
1341:
1098:insulin glargine
1070:insulin glargine
643:
642:
485:Insulin glargine
446:Follitropin alfa
356:Active substance
353:
349:
92:pharmacodynamics
88:pharmacokinetics
7506:
7505:
7501:
7500:
7499:
7497:
7496:
7495:
7476:
7475:
7474:
7464:
7462:
7454:
7423:
7336:
7334:Further reading
7331:
7330:
7320:
7318:
7305:
7304:
7300:
7290:
7288:
7279:
7278:
7274:
7264:
7262:
7249:
7248:
7244:
7234:
7232:
7219:
7218:
7214:
7204:
7202:
7189:
7188:
7184:
7174:
7172:
7159:
7158:
7154:
7144:
7142:
7129:
7128:
7124:
7114:
7112:
7099:
7098:
7094:
7084:
7082:
7069:
7068:
7064:
7054:
7052:
7039:
7038:
7034:
7024:
7022:
7009:
7008:
7004:
6994:
6992:
6979:
6978:
6974:
6964:
6962:
6949:
6948:
6944:
6934:
6932:
6919:
6918:
6914:
6904:
6902:
6889:
6888:
6884:
6874:
6872:
6859:
6858:
6854:
6844:
6842:
6829:
6828:
6824:
6814:
6812:
6799:
6798:
6794:
6784:
6782:
6769:
6768:
6764:
6754:
6752:
6739:
6738:
6734:
6724:
6722:
6709:
6708:
6704:
6694:
6692:
6679:
6678:
6674:
6664:
6662:
6649:
6648:
6644:
6634:
6632:
6619:
6618:
6614:
6604:
6602:
6589:
6588:
6584:
6574:
6572:
6559:
6558:
6554:
6544:
6542:
6529:
6528:
6524:
6514:
6512:
6499:
6498:
6494:
6484:
6482:
6469:
6468:
6464:
6454:
6452:
6439:
6438:
6434:
6424:
6422:
6409:
6408:
6404:
6394:
6392:
6379:
6378:
6374:
6364:
6362:
6349:
6348:
6344:
6334:
6332:
6319:
6318:
6314:
6304:
6302:
6289:
6288:
6284:
6274:
6272:
6259:
6258:
6254:
6244:
6242:
6229:
6228:
6224:
6214:
6212:
6199:
6198:
6194:
6184:
6182:
6169:
6168:
6164:
6154:
6152:
6139:
6138:
6134:
6124:
6122:
6109:
6108:
6104:
6094:
6092:
6079:
6078:
6074:
6064:
6062:
6049:
6048:
6044:
6034:
6032:
6019:
6018:
6014:
6004:
6002:
5989:
5988:
5984:
5974:
5972:
5959:
5958:
5954:
5944:
5942:
5929:
5928:
5924:
5914:
5912:
5899:
5898:
5894:
5884:
5882:
5869:
5868:
5864:
5854:
5852:
5839:
5838:
5834:
5822:
5814:
5812:
5799:
5798:
5783:
5773:
5771:
5754:
5753:
5749:
5739:
5737:
5733:
5694:
5688:
5684:
5672:
5664:
5662:
5649:
5648:
5644:
5634:
5632:
5618:"Zercepac EPAR"
5616:
5615:
5611:
5601:
5599:
5583:
5582:
5578:
5568:
5566:
5550:
5549:
5545:
5535:
5533:
5517:
5516:
5512:
5502:
5500:
5486:"Kanjinti EPAR"
5484:
5483:
5479:
5469:
5467:
5451:
5450:
5446:
5436:
5434:
5418:
5417:
5413:
5403:
5401:
5385:
5384:
5380:
5370:
5368:
5355:
5354:
5350:
5340:
5338:
5322:
5321:
5317:
5307:
5305:
5289:
5288:
5284:
5274:
5272:
5256:
5255:
5251:
5241:
5239:
5223:
5222:
5215:
5205:
5203:
5187:
5186:
5182:
5172:
5170:
5156:"Ruxience EPAR"
5154:
5153:
5149:
5139:
5137:
5121:
5120:
5116:
5106:
5104:
5090:"Rixathon EPAR"
5088:
5087:
5083:
5073:
5071:
5057:"Rituzena EPAR"
5055:
5054:
5050:
5040:
5038:
5024:"Ritemvia EPAR"
5022:
5021:
5017:
5007:
5005:
4991:"Blitzima EPAR"
4989:
4988:
4984:
4974:
4972:
4958:"MabThera EPAR"
4956:
4955:
4951:
4941:
4939:
4923:
4922:
4918:
4908:
4906:
4890:
4889:
4885:
4875:
4873:
4857:
4856:
4852:
4842:
4840:
4826:"Lucentis EPAR"
4824:
4823:
4819:
4809:
4807:
4791:
4790:
4786:
4776:
4774:
4758:
4757:
4753:
4743:
4741:
4725:
4724:
4720:
4710:
4708:
4692:
4691:
4687:
4677:
4675:
4659:
4658:
4654:
4644:
4642:
4626:
4625:
4621:
4611:
4609:
4595:"Fulphila EPAR"
4593:
4592:
4588:
4578:
4576:
4560:
4559:
4555:
4545:
4543:
4529:"Neulasta EPAR"
4527:
4526:
4522:
4512:
4510:
4494:
4493:
4489:
4479:
4477:
4461:
4460:
4456:
4446:
4444:
4428:
4427:
4423:
4413:
4411:
4395:
4394:
4390:
4380:
4378:
4362:
4361:
4357:
4347:
4345:
4329:
4328:
4324:
4314:
4312:
4296:
4295:
4291:
4281:
4279:
4263:
4262:
4258:
4248:
4246:
4230:
4229:
4225:
4215:
4213:
4197:
4196:
4192:
4182:
4180:
4164:
4163:
4159:
4149:
4147:
4131:
4130:
4126:
4116:
4114:
4098:
4097:
4093:
4083:
4081:
4065:
4064:
4060:
4050:
4048:
4032:
4031:
4027:
4017:
4015:
4001:"Remicade EPAR"
3999:
3998:
3994:
3984:
3982:
3966:
3965:
3961:
3951:
3949:
3933:
3932:
3928:
3918:
3916:
3900:
3899:
3895:
3885:
3883:
3867:
3866:
3862:
3852:
3850:
3834:
3833:
3829:
3819:
3817:
3801:
3800:
3796:
3786:
3784:
3768:
3767:
3763:
3753:
3751:
3735:
3734:
3730:
3720:
3718:
3702:
3701:
3697:
3687:
3685:
3669:
3668:
3664:
3654:
3652:
3636:
3635:
3631:
3621:
3619:
3605:"Nivestim EPAR"
3603:
3602:
3595:
3585:
3583:
3567:
3566:
3562:
3552:
3550:
3539:
3538:
3534:
3524:
3522:
3506:
3505:
3501:
3491:
3489:
3475:"Benepali EPAR"
3473:
3472:
3468:
3458:
3456:
3440:
3439:
3435:
3425:
3423:
3407:
3406:
3402:
3392:
3390:
3376:"Retacrit EPAR"
3374:
3373:
3369:
3359:
3357:
3341:
3340:
3336:
3326:
3324:
3310:"Binocrit EPAR"
3308:
3307:
3303:
3293:
3291:
3277:"Abseamed EPAR"
3275:
3274:
3270:
3260:
3258:
3242:
3241:
3237:
3227:
3225:
3209:
3208:
3201:
3191:
3189:
3173:
3172:
3168:
3158:
3156:
3142:"Vegzelma EPAR"
3140:
3139:
3135:
3125:
3123:
3107:
3106:
3102:
3092:
3090:
3074:
3073:
3069:
3059:
3057:
3041:
3040:
3036:
3026:
3024:
3008:
3007:
3003:
2993:
2991:
2977:"Aybintio EPAR"
2975:
2974:
2970:
2960:
2958:
2942:
2941:
2937:
2927:
2925:
2909:
2908:
2904:
2894:
2892:
2876:
2875:
2871:
2861:
2859:
2843:
2842:
2838:
2828:
2826:
2810:
2809:
2805:
2795:
2793:
2779:"Solymbic EPAR"
2777:
2776:
2772:
2762:
2760:
2746:"Libmyris EPAR"
2744:
2743:
2739:
2729:
2727:
2711:
2710:
2706:
2696:
2694:
2678:
2677:
2673:
2663:
2661:
2645:
2644:
2640:
2630:
2628:
2612:
2611:
2607:
2597:
2595:
2579:
2578:
2574:
2564:
2562:
2548:"Hukyndra EPAR"
2546:
2545:
2541:
2531:
2529:
2513:
2512:
2508:
2498:
2496:
2480:
2479:
2475:
2465:
2463:
2447:
2446:
2442:
2432:
2430:
2414:
2413:
2409:
2399:
2397:
2383:"Amgevita EPAR"
2381:
2380:
2376:
2366:
2364:
2348:
2347:
2343:
2333:
2331:
2327:
2316:
2312:
2311:
2307:
2297:
2295:
2279:
2278:
2274:
2227:
2223:
2213:
2211:
2202:
2201:
2197:
2187:
2185:
2181:
2174:
2170:
2169:
2165:
2148:
2147:
2143:
2133:
2131:
2122:
2121:
2117:
2107:
2105:
2092:
2091:
2087:
2077:
2075:
2062:
2061:
2057:
2047:
2045:
2041:
2030:
2024:
2017:
2007:
2005:
1988:
1987:
1983:
1946:
1942:
1932:
1930:
1911:
1907:
1862:
1858:
1853:Wayback Machine
1844:
1840:
1828:
1820:
1818:
1801:
1800:
1793:
1772:
1771:
1767:
1757:
1755:
1751:
1736:
1732:
1731:
1727:
1706:
1705:
1701:
1680:
1679:
1675:
1670:Wayback Machine
1661:
1657:
1647:
1645:
1636:
1635:
1631:
1621:
1619:
1603:
1602:
1598:
1588:
1586:
1582:
1571:
1567:
1566:
1562:
1552:
1550:
1546:
1535:
1531:
1530:
1526:
1516:
1514:
1510:
1499:
1495:
1494:
1490:
1480:
1478:
1474:
1463:
1459:
1458:
1454:
1417:
1413:
1405:
1394:
1390:
1389:
1385:
1354:
1347:
1342:
1338:
1333:
641:
610:
605:
345:
301:
292:
273:
189:recombinant DNA
185:
131:
126:
73:(FDA), and the
30:(also known as
24:
17:
12:
11:
5:
7504:
7494:
7493:
7488:
7473:
7472:
7452:
7451:
7442:
7433:
7422:
7421:External links
7419:
7418:
7417:
7389:(10): 771–80.
7374:
7335:
7332:
7329:
7328:
7298:
7272:
7242:
7212:
7182:
7152:
7122:
7092:
7062:
7032:
7002:
6972:
6942:
6912:
6882:
6852:
6822:
6792:
6762:
6732:
6702:
6672:
6642:
6612:
6582:
6552:
6522:
6492:
6462:
6432:
6402:
6372:
6342:
6312:
6282:
6252:
6222:
6192:
6162:
6132:
6102:
6072:
6042:
6012:
5982:
5952:
5922:
5892:
5862:
5832:
5781:
5747:
5705:(12): 1856–9.
5682:
5642:
5609:
5576:
5543:
5510:
5477:
5453:"Herzuma EPAR"
5444:
5411:
5378:
5348:
5324:"Terrosa EPAR"
5315:
5291:"Movymia EPAR"
5282:
5258:"Forsteo EPAR"
5249:
5213:
5189:"Truxima EPAR"
5180:
5147:
5123:"Riximyo EPAR"
5114:
5081:
5048:
5015:
4982:
4949:
4925:"Ximluci EPAR"
4916:
4883:
4859:"Byooviz EPAR"
4850:
4817:
4784:
4751:
4718:
4685:
4661:"Pelgraz EPAR"
4652:
4619:
4586:
4553:
4520:
4487:
4463:"Humalog EPAR"
4454:
4430:"Semglee EPAR"
4421:
4388:
4355:
4331:"Ryzodeg EPAR"
4322:
4298:"NovoMix EPAR"
4289:
4256:
4223:
4190:
4157:
4124:
4100:"Remsima EPAR"
4091:
4058:
4034:"Flixabi EPAR"
4025:
3992:
3968:"Ovaleap EPAR"
3959:
3935:"Bemfola EPAR"
3926:
3902:"Gonal-f EPAR"
3893:
3860:
3827:
3794:
3761:
3728:
3695:
3662:
3638:"Accofil EPAR"
3629:
3593:
3569:"Nepexto EPAR"
3560:
3541:"Lifmior EPAR"
3532:
3499:
3466:
3433:
3400:
3367:
3334:
3301:
3268:
3235:
3199:
3175:"Zirabev EPAR"
3166:
3133:
3100:
3076:"Onbevzi EPAR"
3067:
3034:
3001:
2968:
2944:"Alymsys EPAR"
2935:
2902:
2878:"Avastin EPAR"
2869:
2845:"Yuflyma EPAR"
2836:
2812:"Trudexa EPAR"
2803:
2770:
2737:
2713:"Kromeya EPAR"
2704:
2680:"Imraldi EPAR"
2671:
2638:
2614:"Hyrimoz EPAR"
2605:
2572:
2539:
2506:
2473:
2449:"Cyltezo EPAR"
2440:
2407:
2374:
2341:
2305:
2272:
2221:
2195:
2163:
2141:
2115:
2085:
2055:
2015:
1981:
1940:
1905:
1856:
1838:
1791:
1765:
1725:
1699:
1673:
1655:
1629:
1596:
1560:
1524:
1488:
1452:
1431:(4): 369–379.
1411:
1383:
1364:(3): 145–152.
1345:
1335:
1334:
1332:
1329:
1326:
1325:
1319:
1316:
1312:
1311:
1305:
1302:
1298:
1297:
1291:
1288:
1284:
1283:
1277:
1274:
1270:
1269:
1263:
1260:
1256:
1255:
1249:
1246:
1245:September 2023
1242:
1241:
1235:
1232:
1228:
1227:
1221:
1218:
1214:
1213:
1207:
1204:
1200:
1199:
1193:
1190:
1189:September 2022
1186:
1185:
1179:
1176:
1175:September 2022
1172:
1171:
1165:
1162:
1158:
1157:
1151:
1148:
1144:
1143:
1137:
1134:
1130:
1129:
1123:
1120:
1116:
1115:
1109:
1106:
1102:
1101:
1095:
1092:
1088:
1087:
1081:
1078:
1077:September 2021
1074:
1073:
1067:
1064:
1060:
1059:
1053:
1050:
1046:
1045:
1039:
1036:
1032:
1031:
1025:
1022:
1018:
1017:
1011:
1008:
1004:
1003:
997:
994:
990:
989:
983:
980:
976:
975:
969:
966:
962:
961:
955:
952:
948:
947:
941:
938:
934:
933:
927:
924:
920:
919:
913:
910:
906:
905:
899:
896:
892:
891:
885:
882:
878:
877:
871:
868:
864:
863:
857:
854:
850:
849:
843:
840:
836:
835:
829:
826:
822:
821:
815:
812:
808:
807:
801:
798:
794:
793:
787:
784:
780:
779:
773:
770:
766:
765:
759:
756:
752:
751:
745:
742:
741:September 2017
738:
737:
731:
728:
724:
723:
717:
714:
710:
709:
703:
700:
699:September 2016
696:
695:
689:
686:
682:
681:
675:
672:
668:
667:
661:
658:
654:
653:
650:
647:
640:
637:
618:Edward Kennedy
609:
606:
604:
601:
598:
597:
594:
591:
585:
584:
581:
578:
572:
571:
568:
565:
559:
558:
555:
552:
546:
545:
542:
539:
533:
532:
529:
526:
520:
519:
516:
513:
507:
506:
503:
500:
498:Insulin lispro
494:
493:
490:
487:
481:
480:
477:
474:
472:Insulin aspart
468:
467:
464:
461:
455:
454:
451:
448:
442:
441:
438:
435:
429:
428:
425:
422:
416:
415:
412:
409:
403:
402:
399:
396:
390:
389:
386:
383:
377:
376:
373:
370:
364:
363:
360:
357:
344:
343:European Union
341:
340:
339:
333:
327:
317:
310:
309:
300:
297:
291:
288:
272:
269:
228:erythropoietin
220:growth hormone
184:
181:
130:
127:
125:
122:
84:immunogenicity
56:small-molecule
15:
9:
6:
4:
3:
2:
7503:
7492:
7489:
7487:
7484:
7483:
7481:
7471:
7461:
7460:
7457:
7450:
7446:
7443:
7441:
7437:
7434:
7432:
7428:
7425:
7424:
7414:
7410:
7406:
7402:
7397:
7392:
7388:
7384:
7380:
7375:
7371:
7367:
7363:
7359:
7355:
7351:
7347:
7343:
7338:
7337:
7316:
7312:
7308:
7302:
7286:
7282:
7276:
7260:
7256:
7252:
7246:
7230:
7226:
7222:
7216:
7200:
7196:
7192:
7186:
7170:
7166:
7162:
7156:
7140:
7136:
7132:
7126:
7115:September 28,
7110:
7106:
7102:
7096:
7080:
7076:
7072:
7066:
7050:
7046:
7042:
7036:
7020:
7016:
7012:
7006:
6990:
6986:
6982:
6976:
6960:
6956:
6952:
6946:
6930:
6926:
6922:
6916:
6900:
6896:
6892:
6886:
6870:
6866:
6862:
6856:
6840:
6836:
6832:
6826:
6810:
6806:
6802:
6796:
6780:
6776:
6772:
6766:
6750:
6746:
6742:
6736:
6720:
6716:
6712:
6706:
6690:
6686:
6682:
6676:
6660:
6656:
6652:
6646:
6630:
6626:
6622:
6616:
6600:
6596:
6592:
6586:
6570:
6566:
6562:
6556:
6540:
6536:
6532:
6526:
6510:
6506:
6502:
6496:
6480:
6476:
6472:
6466:
6450:
6446:
6442:
6436:
6420:
6416:
6412:
6406:
6390:
6386:
6382:
6376:
6360:
6356:
6352:
6346:
6330:
6326:
6322:
6316:
6300:
6296:
6292:
6286:
6270:
6266:
6262:
6256:
6240:
6236:
6232:
6226:
6210:
6206:
6202:
6196:
6180:
6176:
6172:
6166:
6150:
6146:
6142:
6136:
6120:
6116:
6112:
6106:
6090:
6086:
6082:
6076:
6060:
6056:
6052:
6046:
6030:
6026:
6022:
6016:
6000:
5996:
5992:
5986:
5970:
5966:
5962:
5956:
5940:
5936:
5932:
5926:
5910:
5906:
5902:
5896:
5880:
5876:
5872:
5866:
5850:
5846:
5842:
5836:
5829:
5828:public domain
5810:
5806:
5802:
5796:
5794:
5792:
5790:
5788:
5786:
5769:
5765:
5763:
5757:
5751:
5740:September 25,
5732:
5728:
5724:
5720:
5716:
5712:
5708:
5704:
5700:
5693:
5686:
5679:
5678:public domain
5660:
5656:
5652:
5651:"Biosimilars"
5646:
5630:
5626:
5624:
5619:
5613:
5597:
5593:
5591:
5586:
5580:
5564:
5560:
5558:
5553:
5547:
5531:
5527:
5525:
5520:
5519:"Ogivri EPAR"
5514:
5498:
5494:
5492:
5487:
5481:
5465:
5461:
5459:
5454:
5448:
5432:
5428:
5426:
5421:
5415:
5399:
5395:
5393:
5388:
5387:"Tyenne EPAR"
5382:
5366:
5362:
5358:
5352:
5336:
5332:
5330:
5325:
5319:
5303:
5299:
5297:
5292:
5286:
5270:
5266:
5264:
5259:
5253:
5237:
5233:
5231:
5226:
5220:
5218:
5201:
5197:
5195:
5190:
5184:
5168:
5164:
5162:
5157:
5151:
5135:
5131:
5129:
5124:
5118:
5102:
5098:
5096:
5091:
5085:
5069:
5065:
5063:
5058:
5052:
5036:
5032:
5030:
5025:
5019:
5003:
4999:
4997:
4992:
4986:
4970:
4966:
4964:
4959:
4953:
4937:
4933:
4931:
4926:
4920:
4904:
4900:
4898:
4893:
4887:
4871:
4867:
4865:
4860:
4854:
4838:
4834:
4832:
4827:
4821:
4805:
4801:
4799:
4794:
4788:
4772:
4768:
4766:
4761:
4755:
4739:
4735:
4733:
4728:
4722:
4706:
4702:
4700:
4695:
4694:"Pelmeg EPAR"
4689:
4673:
4669:
4667:
4662:
4656:
4640:
4636:
4634:
4629:
4623:
4607:
4603:
4601:
4596:
4590:
4574:
4570:
4568:
4563:
4557:
4541:
4537:
4535:
4530:
4524:
4508:
4504:
4502:
4497:
4491:
4475:
4471:
4469:
4464:
4458:
4442:
4438:
4436:
4431:
4425:
4409:
4405:
4403:
4398:
4392:
4376:
4372:
4370:
4365:
4364:"Lantus EPAR"
4359:
4343:
4339:
4337:
4332:
4326:
4310:
4306:
4304:
4299:
4293:
4282:September 14,
4277:
4273:
4271:
4266:
4265:"Kirsty EPAR"
4260:
4244:
4240:
4238:
4233:
4227:
4211:
4207:
4205:
4200:
4194:
4178:
4174:
4172:
4167:
4161:
4145:
4141:
4139:
4134:
4133:"Zessly EPAR"
4128:
4112:
4108:
4106:
4101:
4095:
4079:
4075:
4073:
4068:
4062:
4046:
4042:
4040:
4035:
4029:
4013:
4009:
4007:
4002:
3996:
3980:
3976:
3974:
3969:
3963:
3947:
3943:
3941:
3936:
3930:
3914:
3910:
3908:
3903:
3897:
3881:
3877:
3875:
3870:
3869:"Zarzio EPAR"
3864:
3848:
3844:
3842:
3837:
3831:
3815:
3811:
3809:
3804:
3798:
3782:
3778:
3776:
3771:
3765:
3749:
3745:
3743:
3738:
3732:
3716:
3712:
3710:
3705:
3699:
3683:
3679:
3677:
3672:
3666:
3650:
3646:
3644:
3639:
3633:
3617:
3613:
3611:
3606:
3600:
3598:
3581:
3577:
3575:
3570:
3564:
3549:
3547:
3542:
3536:
3520:
3516:
3514:
3509:
3508:"Erelzi EPAR"
3503:
3487:
3483:
3481:
3476:
3470:
3454:
3450:
3448:
3443:
3442:"Enbrel EPAR"
3437:
3421:
3417:
3415:
3410:
3409:"Silapo EPAR"
3404:
3388:
3384:
3382:
3377:
3371:
3355:
3351:
3349:
3344:
3338:
3322:
3318:
3316:
3311:
3305:
3289:
3285:
3283:
3278:
3272:
3256:
3252:
3250:
3245:
3239:
3223:
3219:
3217:
3212:
3211:"Inhixa EPAR"
3206:
3204:
3187:
3183:
3181:
3176:
3170:
3154:
3150:
3148:
3143:
3137:
3126:September 11,
3121:
3117:
3115:
3110:
3109:"Oyavas EPAR"
3104:
3093:September 11,
3088:
3084:
3082:
3077:
3071:
3055:
3051:
3049:
3044:
3038:
3022:
3018:
3016:
3011:
3005:
2989:
2985:
2983:
2978:
2972:
2961:September 11,
2956:
2952:
2950:
2945:
2939:
2923:
2919:
2917:
2912:
2911:"Abevmy EPAR"
2906:
2895:September 11,
2890:
2886:
2884:
2879:
2873:
2857:
2853:
2851:
2846:
2840:
2824:
2820:
2818:
2813:
2807:
2791:
2787:
2785:
2780:
2774:
2758:
2754:
2752:
2747:
2741:
2725:
2721:
2719:
2714:
2708:
2692:
2688:
2686:
2681:
2675:
2659:
2655:
2653:
2648:
2647:"Idacio EPAR"
2642:
2626:
2622:
2620:
2615:
2609:
2593:
2589:
2587:
2582:
2576:
2560:
2556:
2554:
2549:
2543:
2527:
2523:
2521:
2516:
2515:"Hefiya EPAR"
2510:
2494:
2490:
2488:
2483:
2477:
2461:
2457:
2455:
2450:
2444:
2428:
2424:
2422:
2417:
2411:
2395:
2391:
2389:
2384:
2378:
2362:
2358:
2356:
2351:
2350:"Humira EPAR"
2345:
2326:
2322:
2315:
2309:
2298:September 19,
2293:
2289:
2287:
2282:
2276:
2268:
2264:
2259:
2254:
2249:
2244:
2240:
2236:
2232:
2225:
2209:
2205:
2199:
2180:
2173:
2167:
2159:
2155:
2151:
2145:
2129:
2125:
2119:
2103:
2099:
2095:
2089:
2073:
2069:
2065:
2059:
2040:
2036:
2029:
2022:
2020:
2003:
1999:
1997:
1991:
1985:
1977:
1973:
1968:
1963:
1959:
1955:
1951:
1944:
1928:
1924:
1920:
1916:
1909:
1901:
1897:
1892:
1887:
1883:
1879:
1875:
1871:
1867:
1860:
1854:
1850:
1847:
1842:
1835:
1834:public domain
1816:
1812:
1810:
1804:
1798:
1796:
1787:
1783:
1781:
1775:
1769:
1750:
1746:
1744:
1735:
1729:
1721:
1717:
1715:
1709:
1703:
1695:
1691:
1689:
1683:
1677:
1671:
1667:
1664:
1659:
1643:
1639:
1633:
1617:
1613:
1611:
1606:
1600:
1581:
1578:(WHO). 2017.
1577:
1570:
1564:
1545:
1542:(WHO). 2018.
1541:
1534:
1528:
1509:
1506:(WHO). 2013.
1505:
1498:
1492:
1473:
1469:
1462:
1456:
1448:
1444:
1439:
1434:
1430:
1426:
1422:
1415:
1404:
1400:
1393:
1387:
1379:
1375:
1371:
1367:
1363:
1359:
1352:
1350:
1340:
1336:
1323:
1320:
1317:
1314:
1313:
1309:
1306:
1303:
1300:
1299:
1295:
1292:
1289:
1287:February 2024
1286:
1285:
1281:
1278:
1275:
1273:December 2023
1272:
1271:
1267:
1264:
1261:
1258:
1257:
1253:
1250:
1247:
1244:
1243:
1239:
1236:
1233:
1230:
1229:
1225:
1222:
1219:
1216:
1215:
1211:
1208:
1205:
1203:December 2022
1202:
1201:
1197:
1194:
1191:
1188:
1187:
1183:
1182:pegfilgrastim
1180:
1177:
1174:
1173:
1169:
1166:
1163:
1160:
1159:
1155:
1154:pegfilgrastim
1152:
1149:
1146:
1145:
1141:
1138:
1135:
1132:
1131:
1127:
1124:
1121:
1119:February 2022
1118:
1117:
1113:
1110:
1107:
1105:December 2021
1104:
1103:
1099:
1096:
1093:
1091:December 2021
1090:
1089:
1085:
1082:
1079:
1076:
1075:
1071:
1068:
1065:
1062:
1061:
1057:
1054:
1051:
1049:December 2020
1048:
1047:
1043:
1040:
1037:
1034:
1033:
1029:
1028:pegfilgrastim
1026:
1023:
1020:
1019:
1015:
1012:
1009:
1007:December 2019
1006:
1005:
1001:
998:
995:
993:November 2019
992:
991:
987:
986:pegfilgrastim
984:
981:
979:November 2019
978:
977:
973:
970:
967:
964:
963:
959:
956:
953:
950:
949:
945:
942:
939:
936:
935:
931:
928:
925:
922:
921:
917:
914:
911:
908:
907:
903:
900:
897:
894:
893:
889:
886:
883:
880:
879:
875:
872:
869:
867:December 2018
866:
865:
861:
858:
855:
853:November 2018
852:
851:
847:
846:pegfilgrastim
844:
841:
839:November 2018
838:
837:
833:
830:
827:
824:
823:
819:
816:
813:
810:
809:
805:
804:pegfilgrastim
802:
799:
796:
795:
791:
788:
785:
782:
781:
777:
774:
771:
769:December 2017
768:
767:
763:
760:
757:
755:December 2017
754:
753:
749:
746:
743:
740:
739:
735:
732:
729:
726:
725:
721:
718:
715:
712:
711:
707:
704:
701:
698:
697:
693:
690:
687:
684:
683:
679:
676:
673:
670:
669:
665:
662:
659:
656:
655:
651:
648:
645:
644:
636:
634:
629:
627:
623:
619:
615:
603:United States
595:
592:
590:
587:
586:
582:
579:
577:
574:
573:
569:
566:
564:
561:
560:
556:
553:
551:
548:
547:
543:
540:
538:
535:
534:
530:
527:
525:
522:
521:
517:
514:
512:
511:Pegfilgrastim
509:
508:
504:
501:
499:
496:
495:
491:
488:
486:
483:
482:
478:
475:
473:
470:
469:
465:
462:
460:
457:
456:
452:
449:
447:
444:
443:
439:
436:
434:
431:
430:
426:
423:
421:
418:
417:
413:
410:
408:
405:
404:
400:
397:
395:
392:
391:
387:
384:
382:
379:
378:
374:
371:
369:
366:
365:
361:
358:
355:
354:
348:
337:
334:
331:
328:
325:
321:
320:Reimbursement
318:
315:
312:
311:
307:
306:
305:
296:
287:
285:
280:
276:
268:
264:
260:
257:
251:
247:
244:
239:
235:
233:
229:
225:
221:
217:
212:
209:
204:
202:
198:
194:
190:
180:
176:
174:
169:
164:
162:
158:
154:
150:
145:
143:
138:
136:
129:United States
121:
119:
115:
111:
107:
102:
100:
95:
93:
89:
85:
80:
79:Health Canada
76:
72:
68:
63:
61:
57:
53:
52:generic drugs
48:
46:
41:
37:
33:
29:
22:
7386:
7382:
7345:
7341:
7321:November 13,
7319:. Retrieved
7301:
7291:November 26,
7289:. Retrieved
7275:
7265:November 26,
7263:. Retrieved
7245:
7233:. Retrieved
7215:
7203:. Retrieved
7185:
7173:. Retrieved
7155:
7143:. Retrieved
7125:
7113:. Retrieved
7095:
7083:. Retrieved
7065:
7053:. Retrieved
7035:
7023:. Retrieved
7005:
6993:. Retrieved
6975:
6963:. Retrieved
6945:
6933:. Retrieved
6915:
6903:. Retrieved
6885:
6873:. Retrieved
6855:
6845:December 17,
6843:. Retrieved
6825:
6815:December 17,
6813:. Retrieved
6795:
6785:December 17,
6783:. Retrieved
6765:
6755:December 17,
6753:. Retrieved
6735:
6725:December 17,
6723:. Retrieved
6705:
6695:December 17,
6693:. Retrieved
6675:
6665:December 17,
6663:. Retrieved
6645:
6635:December 17,
6633:. Retrieved
6615:
6605:December 17,
6603:. Retrieved
6585:
6575:December 17,
6573:. Retrieved
6555:
6545:December 17,
6543:. Retrieved
6525:
6515:December 17,
6513:. Retrieved
6495:
6485:December 17,
6483:. Retrieved
6465:
6455:December 17,
6453:. Retrieved
6435:
6425:December 17,
6423:. Retrieved
6405:
6395:December 17,
6393:. Retrieved
6375:
6365:December 17,
6363:. Retrieved
6345:
6335:November 26,
6333:. Retrieved
6315:
6305:December 17,
6303:. Retrieved
6285:
6275:November 26,
6273:. Retrieved
6255:
6245:December 17,
6243:. Retrieved
6225:
6215:December 17,
6213:. Retrieved
6195:
6185:November 26,
6183:. Retrieved
6165:
6155:December 17,
6153:. Retrieved
6135:
6125:November 26,
6123:. Retrieved
6105:
6095:December 17,
6093:. Retrieved
6075:
6063:. Retrieved
6045:
6035:December 17,
6033:. Retrieved
6015:
6005:November 26,
6003:. Retrieved
5985:
5975:December 17,
5973:. Retrieved
5955:
5945:November 26,
5943:. Retrieved
5925:
5915:December 17,
5913:. Retrieved
5895:
5885:November 26,
5883:. Retrieved
5865:
5855:December 17,
5853:. Retrieved
5835:
5813:. Retrieved
5774:December 16,
5772:. Retrieved
5759:
5750:
5738:. Retrieved
5731:the original
5702:
5698:
5685:
5663:. Retrieved
5654:
5645:
5633:. Retrieved
5621:
5612:
5600:. Retrieved
5588:
5579:
5567:. Retrieved
5555:
5546:
5534:. Retrieved
5522:
5513:
5501:. Retrieved
5489:
5480:
5468:. Retrieved
5456:
5447:
5435:. Retrieved
5423:
5414:
5402:. Retrieved
5390:
5381:
5369:. Retrieved
5360:
5351:
5339:. Retrieved
5327:
5318:
5306:. Retrieved
5294:
5285:
5273:. Retrieved
5261:
5252:
5240:. Retrieved
5228:
5206:September 8,
5204:. Retrieved
5192:
5183:
5173:September 8,
5171:. Retrieved
5159:
5150:
5140:September 8,
5138:. Retrieved
5126:
5117:
5107:September 8,
5105:. Retrieved
5093:
5084:
5074:September 8,
5072:. Retrieved
5060:
5051:
5041:September 8,
5039:. Retrieved
5027:
5018:
5008:September 8,
5006:. Retrieved
4994:
4985:
4975:September 8,
4973:. Retrieved
4961:
4952:
4940:. Retrieved
4928:
4919:
4907:. Retrieved
4895:
4886:
4876:September 9,
4874:. Retrieved
4862:
4853:
4843:September 9,
4841:. Retrieved
4829:
4820:
4808:. Retrieved
4796:
4787:
4775:. Retrieved
4763:
4754:
4742:. Retrieved
4730:
4721:
4709:. Retrieved
4697:
4688:
4676:. Retrieved
4664:
4655:
4643:. Retrieved
4631:
4622:
4610:. Retrieved
4598:
4589:
4577:. Retrieved
4565:
4556:
4544:. Retrieved
4532:
4523:
4513:September 9,
4511:. Retrieved
4499:
4490:
4478:. Retrieved
4466:
4457:
4445:. Retrieved
4433:
4424:
4412:. Retrieved
4400:
4391:
4379:. Retrieved
4367:
4358:
4346:. Retrieved
4334:
4325:
4313:. Retrieved
4301:
4292:
4280:. Retrieved
4268:
4259:
4249:September 9,
4247:. Retrieved
4235:
4226:
4214:. Retrieved
4202:
4199:"Fiasp EPAR"
4193:
4181:. Retrieved
4169:
4160:
4148:. Retrieved
4136:
4127:
4115:. Retrieved
4103:
4094:
4082:. Retrieved
4070:
4061:
4049:. Retrieved
4037:
4028:
4016:. Retrieved
4004:
3995:
3985:September 9,
3983:. Retrieved
3971:
3962:
3952:September 9,
3950:. Retrieved
3938:
3929:
3917:. Retrieved
3905:
3896:
3884:. Retrieved
3872:
3863:
3851:. Retrieved
3839:
3830:
3818:. Retrieved
3806:
3797:
3785:. Retrieved
3773:
3764:
3752:. Retrieved
3740:
3731:
3719:. Retrieved
3707:
3698:
3686:. Retrieved
3674:
3665:
3653:. Retrieved
3641:
3632:
3620:. Retrieved
3608:
3584:. Retrieved
3572:
3563:
3551:. Retrieved
3544:
3535:
3523:. Retrieved
3511:
3502:
3490:. Retrieved
3478:
3469:
3457:. Retrieved
3445:
3436:
3424:. Retrieved
3412:
3403:
3391:. Retrieved
3379:
3370:
3358:. Retrieved
3346:
3337:
3325:. Retrieved
3313:
3304:
3292:. Retrieved
3280:
3271:
3259:. Retrieved
3247:
3238:
3228:September 9,
3226:. Retrieved
3214:
3190:. Retrieved
3178:
3169:
3157:. Retrieved
3145:
3136:
3124:. Retrieved
3112:
3103:
3091:. Retrieved
3079:
3070:
3058:. Retrieved
3046:
3043:"Mvasi EPAR"
3037:
3025:. Retrieved
3013:
3004:
2994:September 9,
2992:. Retrieved
2980:
2971:
2959:. Retrieved
2947:
2938:
2926:. Retrieved
2914:
2905:
2893:. Retrieved
2881:
2872:
2860:. Retrieved
2848:
2839:
2827:. Retrieved
2815:
2806:
2794:. Retrieved
2782:
2773:
2761:. Retrieved
2749:
2740:
2728:. Retrieved
2716:
2707:
2695:. Retrieved
2683:
2674:
2662:. Retrieved
2650:
2641:
2629:. Retrieved
2617:
2608:
2596:. Retrieved
2584:
2581:"Hulio EPAR"
2575:
2563:. Retrieved
2551:
2542:
2530:. Retrieved
2518:
2509:
2497:. Retrieved
2485:
2476:
2464:. Retrieved
2452:
2443:
2431:. Retrieved
2419:
2410:
2398:. Retrieved
2386:
2377:
2365:. Retrieved
2353:
2344:
2332:. Retrieved
2320:
2308:
2296:. Retrieved
2284:
2275:
2238:
2234:
2224:
2214:December 30,
2212:. Retrieved
2198:
2186:. Retrieved
2166:
2158:the original
2153:
2144:
2134:December 29,
2132:. Retrieved
2118:
2108:December 29,
2106:. Retrieved
2097:
2088:
2078:December 20,
2076:. Retrieved
2067:
2058:
2048:December 23,
2046:. Retrieved
2034:
2006:. Retrieved
1993:
1984:
1960:(2): 153–6.
1957:
1953:
1943:
1931:. Retrieved
1925:(6): 32–37.
1922:
1918:
1908:
1873:
1869:
1859:
1841:
1821:December 17,
1819:. Retrieved
1806:
1786:the original
1777:
1768:
1758:December 16,
1756:. Retrieved
1740:
1728:
1720:the original
1711:
1702:
1694:the original
1685:
1676:
1658:
1646:. Retrieved
1642:the original
1632:
1620:. Retrieved
1608:
1599:
1589:December 18,
1587:. Retrieved
1563:
1553:December 18,
1551:. Retrieved
1527:
1517:December 18,
1515:. Retrieved
1491:
1479:. Retrieved
1472:the original
1455:
1428:
1424:
1414:
1403:the original
1398:
1386:
1361:
1357:
1339:
1259:October 2023
881:January 2019
825:October 2018
790:epoetin alfa
633:evergreening
630:
611:
563:Teriparatide
407:Epoetin alfa
346:
335:
329:
319:
313:
302:
293:
281:
277:
274:
271:Nomenclature
265:
261:
252:
248:
240:
236:
213:
205:
186:
177:
165:
146:
139:
132:
103:
96:
64:
50:Unlike with
49:
35:
31:
27:
25:
7348:(1): 13–4.
3027:October 12,
1876:(1): 7–14.
1481:October 24,
1280:bevacizumab
1266:ustekinumab
1252:tocilizumab
1238:natalizumab
1231:August 2023
1196:bevacizumab
1168:ranibizumab
1161:August 2022
1140:bevacizumab
1084:ranibizumab
944:bevacizumab
932:/Herceptin
930:trastuzumab
904:/Herceptin
902:trastuzumab
890:/Herceptin
888:trastuzumab
876:/Herceptin
874:trastuzumab
764:/Herceptin
762:trastuzumab
748:bevacizumab
727:August 2017
685:August 2016
589:Trastuzumab
576:Tocilizumab
524:Ranibizumab
411:Eprex/Erypo
381:Bevacizumab
224:interferons
7480:Categories
7235:August 25,
7205:August 25,
7175:August 25,
7145:August 25,
7085:August 25,
6935:August 25,
6875:August 28,
6065:August 28,
5815:August 28,
5665:August 28,
4909:October 6,
4348:August 27,
4315:August 27,
4216:August 27,
2928:August 27,
2862:August 27,
2829:August 27,
2796:August 27,
2730:August 27,
2466:August 27,
1933:August 13,
1648:October 8,
1574:(Report).
1538:(Report).
1502:(Report).
1466:(Report).
1331:References
1315:March 2024
1301:March 2024
1294:adalimumab
1224:adalimumab
1210:adalimumab
1184:/Neulasta
1170:/Lucentis
1156:/Neulasta
1133:April 2022
1128:/Neupogen
1126:filgrastim
1112:adalimumab
1086:/Lucentis
1042:adalimumab
1030:/Neulasta
1016:/Remicade
1014:infliximab
1000:adalimumab
988:/Neulasta
972:adalimumab
916:etanercept
909:April 2019
895:March 2019
848:/Neulasta
832:adalimumab
820:/Neupogen
818:filgrastim
806:/Neulasta
778:/Remicade
776:infliximab
734:adalimumab
722:/Remicade
720:infliximab
713:April 2017
706:adalimumab
692:etanercept
680:/Remicade
678:infliximab
671:April 2016
666:/Neupogen
664:filgrastim
657:March 2015
557:Omnitrope
554:Genotropin
550:Somatropin
459:Infliximab
433:Filgrastim
420:Etanercept
368:Adalimumab
201:cell-based
183:Background
157:Genotropin
153:Enoxaparin
114:filgrastim
110:infliximab
28:biosimilar
7413:205293428
4727:"Udenyca"
2763:April 23,
2697:April 21,
2664:April 21,
2631:April 21,
2598:April 21,
2565:April 23,
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