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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Let’s Connect

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:

 

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March 1-3, 2027 | Orlando, FL

Access! 2027 offers an opportunity to meet with industry leaders shaping the future of generics and biosimilars. Be inspired by exciting experiences and innovative ideas as our industry convenes to tackle challenges and embrace opportunities. Registration to open soon.