FDA-Approved Biosimilars

Monday September 20, 2021

Scroll down to find an updated list of all FDA-approved biosimilars. This list includes information on when biosimilars were approved, when they became available to patients and which biologic they reference.

The market for FDA-approved biosimilars is expanding, as they now approach nearly 30% of the overall biologics market. The average sales price for biosimilars is on average 50% less than the reference brand biologic price. Further, competition from biosimilars has reduced the average sales price of their corresponding reference biologic by an average of 25%

For more information about how biosimilars benefit patients, visit our resources page or the FDA website.

Biosimilar Information

BiosimilarU.S. MarketerApproval DateLaunched
10Retacrit Pfizer05/2018
6CyltezoBoehringer Ingelheim08/2017
15Truxima Teva11/2018
34ReleukoAmneal02/2022
25AbriladaPfizer11/2019
37Cimerli Coherus08/2022
29RiabniAmgen12/2020
27NyvepriaPfizer06/2020
7MvasiAmgen09/2017
20Kanjinti Amgen06/2019
14UdenycaCoherus11/2018
5RenflexisOrganon05/2017
11FulphilaBiocon06/2018
12NivestymPfizer07/2018
1ZarxioSandoz03/2015
41VegzelmaCelltrion09/2022
33Yusimry Coherus12/2021
38StimufendFresnius Kabi09/2022
9IxifiPfizer12/2017TBD
28HulioBiocon/Fujifilm07/2020TBD
19EticovoSamsung Bioepis 04/2019TBD
32RezvoglarEli Lilly and Co12/2021
40IdacioFresnius Kabi12/2022
13HyrimozSandoz08/2018
36Fylnetra Amneal05/2022
35Alymsys Amneal04/2022
8OgivriBiocon12/2017
22RuxiencePfizer07/2019
18TrazimeraPfizer03/2019
17OntruzantOrganon01/2019
26AvsolaAmgen12/2019
16HerzumaTeva12/2018
24ZiextenzoSandoz11/2019
4AmjevitaAmgen12/2016
3ErelziSandoz08/20162029
2InflectraPfizer04/2016
30SemgleeBiocon07/2021
31Byoovizbiogen09/2021
23HadlimaSamsung Bioepis 07/2019
21ZirabevPfizer06/2019
42TyrukoSandoz08/20232024
44WezlanaAmgen11/2023TBD
45AvziviBio-Thera Solutions12/2023TBD
46SimlandiTeva and Alvotech02/2024TBD
47Jubbonti and WyostSandoz03/202405/2025
48TyenneFresenius Kabi03/2024TBD
49SelarsdiAlvotech and Teva04/202402/2025
50HercessiAccord BioPharma04/2024TBD
51OpuvizEylea05/2024TBD
52YesafiliEylea05/2024TBD
41YuflymaCelltrion05/2023
43TofidenceBio-Thera Solution09/2023TBD
Total: 53 approved, 38 launched
Source: FDA
As of May 2024

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 20 percent of total drug spending.

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Get Involved

The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:

 

 

October 21–23, 2024 | Rockville, MD

GRx+Biosims™ 2024 is the leading regulatory science and policy event for the U.S. generics and biosimilars industry. Access the most recent information straight from experts at the Food and Drug Administration, grasp the latest policies shaping the industry, and acquire valuable insights to propel your professional development.