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. MarketerDateLaunched
9IxifiPfizer12/2014TBD
15ZarxioSandoz09/2015
2ErelziSandoz08/2016TBD
37InflectraPfizer11/2016
16RenflexisOrganon07/2018
17FulphilaBiocon07/2018
18NivestymPfizer10/2018
19Retacrit Pfizer11/2018
20UdenycaCoherus01/2019
21Kanjinti Amgen07/2019
22MvasiAmgen07/2019
3EticovoSamsung Bioepis 08/2019TBD
40Truxima Teva11/2019
23OgivriBiocon11/2019
24ZiextenzoSandoz11/2019
25ZirabevPfizer01/2020
26RuxiencePfizer01/2020
28TrazimeraPfizer02/2020
27HerzumaTeva03/2020
29OntruzantOrganon04/2020
30AvsolaAmgen07/2020
6HulioBiocon/Fujifilm07/2020TBD
32NyvepriaPfizer12/2020
33RiabniAmgen01/2021
31SemgleeBiocon11/2021
10RezvoglarEli Lilly and Co12/2021
39ReleukoAmneal03/2022
4Fylnetra Amneal05/2022
38Byoovizbiogen06/2022
35Cimerli Coherus08/2022
13Vegzelma Celltrion09/2022
34Alymsys Amneal10/2022
14AmjevitaAmgen02/2023
11StimufendFresnius Kabi02/2023
7HyrimozSandoz03/2023
44YuffymaCelltrion05/2023TBD
1CyltezoBoehringer Ingelheim07/2023
8IdacioFresnius Kabi07/2023
5HadlimaSamsung Bioepis 07/2023
36AbriladaPfizer07/2023
12Yusimry Coherus07/2023
43TyrukoSandoz08/2023TBD
Ustekinumab-auubAmgen11/2023TBD
Total: 42 approved, 36 launched
Source: FDA
As of August 2023

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:

 

 

Register Now! February 5–7, 2024 | Tampa, Florida

AAM’s annual meeting Access! 2024 brings together policymakers, influential speakers and industry leaders to chart the future of generics and biosimilars. Discussions center around the business, breakthroughs and politics that shape our industry. It’s the opportunity to hear firsthand from world-renowned speakers and learn about where our industry is heading and what our future holds.