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.

FDA Biosimilars Approvals

BiosimilarApproved Launched
AVASTIN (BEVACIZUMAB)
Alymsy (bevacizumab-maly)Apr-22Oct-22
Mvasi (bevacizumab-awwb)Sep-17Jul-19
Zirabev (bevacizumab-bvzr)Jun-19Dec-19
Vegzelma, Celltrion (bevacizumab-adcd)Sep-22
ENBREL (ETANERCEPT)
Erelzi (etanercept-szzs)Aug-16
Eticovo (etanercept-ykro)Apr-19
EPOGEN/PROCRIT (EPOETIN ALFA)
Retacrit (epoetinalfa-epbx)May-18Nov-18
HERCEPTIN (TRASTUZUMAB)
Ogivri (trastuzumab-dkst)Dec-17Dec-19
Herzuma (trastuzumab-pkrb)Dec-18Mar-20
Ontruzant (trastuzumab-dttb)Jan-19Apr-20
Trazimera (trastuzumab-qyyp) Mar-19Feb-20
Kanjinti (trastuzumab-anns)Jun-19Jul-19
HUMIRA (ADALIMUMAB)
Amjevita (adalimumab-atto)Sep-16
Cyltezo (adalimumab-adbm)Sep-16
Hyrimoz (adalimumab-adaz)Oct-18
Hadlima (adalimumab-bwwd)*Jul-19, Aug-22
Abrilada (adalimumab-afzb)Nov-19
Hulio (adalimumab-fkjp)Jul-20
Yusimry (adalimumab-aqvh)Dec-21
LANTUS (INSULIN GLARGINE)
Rezvoglar (insuline glargine-aglr)Dec-21
Semglee (insulin glargine-yfgn)Jul-21Nov-21
LUCENTIS (RANIBIZUMAB)
Byooviz (ranibizumab-nuna)Sep-21Jul-22
Cimerli (ranibizumab-eqrn)Aug-22Oct-22
NEULASTA (PEGFILGRASTIM)
Fulphila (pegfilgrastim-jmdb)Jun-18Jun-18
Nyvepria (pegfilgrastim-apgf)Jun-20Dec-20
Udenyca (pegfilgrastim-cbqv)Nov-18Jan-19
Ziextenzo (pegfilgrastim-bmez)Nov-19Dec-19
Fylnetra (pegfilgrastim-pbbk)May-22
Stimufend (pegfilgrastim-fpgk)Sep-22
NEUPOGEN (FILGRASTIM)
Zarxio (filgrastim-sndz)Mar-15Sep-15
Nivestym (filgrastim-aafi) Jul-18Oct-18
Releuko (filgrastim-ayow)Mar-22
REMICADE (INFLIXIMAB)
Inflectra (infliximab-dyyb)Apr-16Nov-16
Renflexis (infliximab-abda)Apr-17Jul-17
Ixifi (infliximab-qbtx)Dec-17
Avsola (infliximab-axxq)Dec-19Jul-20
RITUXAN (RITUXIMAB)
Truxima (rituximab-abbs)Nov-18Nov-19
Ruxience (rituximab-pvvr)Jul-19Feb-20
Riabni (rituximab-arrx)Dec-20Jan-21
Total: 39 approved, 23 launchedAs of October 2022
Source: FDA
*A high concentrate (August 2022) and low concentrate (July 2019) version of Hadlima are approved

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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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! November 7-9 | North Bethesda, MD

GRx+Biosims is the premier scientific and regulatory event for the generics and biosimilars industry. This year’s conference will be held in-person for the first time since 2019!

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