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How many biosimilars have been approved in the United States?

Medically reviewed by Judith Stewart, BPharm. Last updated on Dec 23, 2022.

What are the biosimilars for Avastin, Enbrel, Epogen, Herceptin, Humira, Lantus, Lucentis, Neulasta, Neupogen, Remicade, and Rituxan? List of all biosimilars approved in the United States.

Official answer

by Drugs.com

The are currently 40 approved biosimilars approved by the FDA (Food and Drug Administration). The most recent biosimilar approval was Idacio (adalimumab-aacf) on December 13, 2022.

What is a Biosimilar?

According the to FDA, a biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from an existing FDA-approved reference product.

Biological products are a diverse category of products, and include therapeutic proteins (example filgrastim) and monoclonal antibodies (example adalimumab). Biological products are generally large, complex molecules, and inherent variations are normal and expected within the manufacturing process.

A manufacturer developing a biosimilar will need to demonstrate that its product is highly similar to the characteristics of the reference product in terms of purity, chemical identity, and bioactivity. The manufacturer must also demonstrate that its product has no clinically meaningful differences to the reference product in terms of safety, purity, and potency (safety and effectiveness) which is determined though human pharmacokinetic and pharmacodynamic studies, and additional clinical studies if needed.

Biosimilar products can only be dispensed in place of another biological product if the health care provider specifically prescribes the biosimilar product by name.

What is an Interchangeable?

An interchangeable product is a biological product that meets all the requirements for a biosimilar product, but also meets additional requirements outlined by the Biologics Price Competition and Innovation Act.

A manufacturer developing an interchangeable product will need to demonstrate that its product is expected to produce the same clinical result as the reference product in any given patient. If a product is to be administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product will need to have been evaluated.

Interchangeable products may be substituted at pharmacy-level without the intervention of the health care provider who prescribed the reference product. A health care provider also can prescribe an interchangeable product just like they would prescribe a biosimilar or a reference product. (Note that pharmacy laws and practices vary from state to state.)

Learn about cost-savings, clinical use, and safety of biosimilars.

Biosimilars by reference product (or by approval date)

Avastin (bevacizumab) biosimilars
Name Regulatory Designation Company Name FDA Approved
Vegzelma
(bevacizumab-adcd)
Biosimilar Celltrion, Inc. September 27, 2022
Alymsys
(bevacizumab-maly)
Biosimilar Amneal Pharmaceuticals, Inc. April 13, 2022
Zirabev
(bevacizumab-bvzr)
Biosimilar Pfizer Inc. June 27, 2019
Mvasi
(bevacizumab-awwb)
Biosimilar Amgen Inc. September 14, 2017
Enbrel (etanercept) biosimilars
Name Regulatory Designation Company Name FDA Approved
Eticovo
(etanercept-ykro)
Biosimilar Samsung Bioepis Co., Ltd. April 25, 2019
Erelzi
(etanercept-szzs)
Biosimilar Sandoz Inc. August 30, 2016
Epogen / Procrit (epoetin alfa) biosimilars
Name Regulatory Designation Company Name FDA Approved
Retacrit
(epoetin alfa-epbx)
Biosimilar Hospira Inc. May 15, 2018
Herceptin (trastuzumab) biosimilars
Name Regulatory Designation Company Name FDA Approved
Kanjinti
(trastuzumab-anns)
Biosimilar Amgen Inc. June 13, 2019
Trazimera
(trastuzumab-qyyp)
Biosimilar Pfizer Inc. March 11, 2019
Ontruzant
(trastuzumab-dttb)
Biosimilar Samsung Bioepis Co., Ltd. January 18, 2019
Herzuma
(trastuzumab-pkrb)
Biosimilar Celltrion, Inc. December 14, 2018
Ogivri
(trastuzumab-dkst)
Biosimilar Mylan GmbH December 1, 2017
Humira (adalimumab) biosimilars
Name Regulatory Designation Company Name FDA Approved
Idacio
(adalimumab-aacf)
Biosimilar Fresenius Kabi December 13, 2022
Yusimry
(adalimumab-aqvh)
Biosimilar Coherus BioSciences, Inc. December 17, 2021
Hulio
(adalimumab-fkjp)
Biosimilar Mylan Pharmaceuticals Inc. July 6, 2020
Abrilada
(adalimumab-afzb)
Biosimilar Pfizer Inc. November 15, 2019
Hadlima
(adalimumab-bwwd)
Biosimilar Samsung Bioepis Co., Ltd. July 23, 2019
Hyrimoz
(adalimumab-adaz)
Biosimilar Sandoz Inc. October 30, 2018
Cyltezo
(adalimumab-adbm)
Interchangeable Boehringer Ingelheim Pharmaceuticals, Inc. August 25, 2017
Amjevita
(adalimumab-atto)
Biosimilar Amgen Inc. September 23, 2016
Lantus (insulin glargine) biosimilars
Name Regulatory Designation Company Name FDA Approved
Rezvoglar
(insulin glargine-aglr)
Interchangeable Eli Lilly and Company December 17, 2021
Semglee
(insulin glargine-yfgn)
Interchangeable Mylan Pharmaceuticals Inc. July 28, 2021
Lucentis (ranibizumab) biosimilars
Name Regulatory Designation Company Name FDA Approved
Cimerli
(ranibizumab-eqrn)
Interchangeable Coherus BioSciences, Inc. August 2, 2022
Byooviz
(ranibizumab-nuna)
Biosimilar Samsung Bioepis Co., Ltd. September 17, 2021
Neulasta (pegfilgrastim) biosimilars
Name Regulatory Designation Company Name FDA Approved
Stimufend
(pegfilgrastim-fpgk)
Biosimilar Fresenius Kabi USA, LLC September 1, 2022
Fylnetra
(pegfilgrastim-pbbk)
Biosimilar Amneal Pharmaceuticals, Inc. May 26, 2022
Nyvepria
(pegfilgrastim-apgf)
Biosimilar Pfizer Inc. June 10, 2020
Ziextenzo
(pegfilgrastim-bmez)
Biosimilar Sandoz Inc. November 4, 2019
Udenyca
(pegfilgrastim-cbqv)
Biosimilar Coherus BioSciences, Inc. November 2, 2018
Fulphila
(pegfilgrastim-jmdb)
Biosimilar Mylan N.V. June 4, 2018
Neupogen (filgrastim) biosimilars
Name Regulatory Designation Company Name FDA Approved
Releuko
(filgrastim-ayow)
Biosimilar Kashiv BioSciences, LLC February 25, 2022
Nivestym
(filgrastim-aafi)
Biosimilar Pfizer Inc. July 20, 2018
Zarxio
(filgrastim-sndz)
Biosimilar Sandoz Inc. March 6, 2015
Remicade (infliximab) biosimilars
Name Regulatory Designation Company Name FDA Approved
Avsola
(infliximab-axxq)
Biosimilar Amgen Inc. December 6, 2019
Ixifi
(infliximab-qbtx)
Biosimilar Pfizer Inc. December 13, 2017
Renflexis
(infliximab-abda)
Biosimilar Samsung Bioepis Co., Ltd. April 21, 2017
Inflectra
(infliximab-dyyb)
Biosimilar Celltrion, Inc. April 5, 2016
Rituxan (rituximab) biosimilars
Name Regulatory Designation Company Name FDA Approved
Riabni
(rituximab-arrx)
Biosimilar Amgen Inc. December 17, 2020
Ruxience
(rituximab-pvvr)
Biosimilar Pfizer Inc. July 23, 2019
Truxima
(rituximab-abbs)
Biosimilar Celltrion, Inc. November 28, 2018

Biosimilars by approval date

  1. Idacio (adalimumab-aacf) - December 13, 2022
  2. Vegzelma (bevacizumab-adcd) - September 27, 2022
  3. Stimufend (pegfilgrastim-fpgk) - September 1, 2022
  4. Cimerli (ranibizumab-eqrn) - August 2, 2022
  5. Fylnetra (pegfilgrastim-pbbk) - May 26, 2022
  6. Alymsys (bevacizumab-maly) - April 13, 2022
  7. Releuko (filgrastim-ayow) - February 25, 2022
  8. Yusimry (adalimumab-aqvh) - December 17, 2021
  9. Rezvoglar (insulin glargine-aglr) - December 17, 2021
  10. Byooviz (ranibizumab-nuna) - September 17, 2021
  11. Semglee (insulin glargine-yfgn) - July 28, 2021
  12. Riabni (rituximab-arrx) - December 17, 2020
  13. Hulio (adalimumab-fkjp) - July 6, 2020
  14. Nyvepria (pegfilgrastim-apgf) - June 10, 2020
  15. Avsola (infliximab-axxq) - December 6, 2019
  16. Abrilada (adalimumab-afzb) - November 15, 2019
  17. Ziextenzo (pegfilgrastim-bmez) - November 4, 2019
  18. Hadlima (adalimumab-bwwd) - July 23, 2019
  19. Ruxience (rituximab-pvvr) - July 23, 2019
  20. Zirabev (bevacizumab-bvzr) - June 27, 2019
  21. Kanjinti (trastuzumab-anns) - June 13, 2019
  22. Eticovo (etanercept-ykro) - April 25, 2019
  23. Trazimera (trastuzumab-qyyp) - March 11, 2019
  24. Ontruzant (trastuzumab-dttb) - January 18, 2019
  25. Herzuma (trastuzumab-pkrb) - December 14, 2018
  26. Truxima (rituximab-abbs) - November 28, 2018
  27. Udenyca (pegfilgrastim-cbqv) - November 2, 2018
  28. Hyrimoz (adalimumab-adaz) - October 30, 2018
  29. Nivestym (filgrastim-aafi) - July 20, 2018
  30. Fulphila (pegfilgrastim-jmdb) - June 4, 2018
  31. Retacrit (epoetin alfa-epbx) - May 15, 2018
  32. Ixifi (infliximab-qbtx) - December 13, 2017
  33. Ogivri (trastuzumab-dkst) - December 1, 2017
  34. Mvasi (bevacizumab-awwb) - September 14, 2017
  35. Cyltezo (adalimumab-adbm) - August 25, 2017
  36. Renflexis (infliximab-abda) - April 21, 2017
  37. Amjevita (adalimumab-atto) - September 23, 2016
  38. Erelzi (etanercept-szzs) - August 30, 2016
  39. Inflectra (infliximab-dyyb) - April 5, 2016
  40. Zarxio (filgrastim-sndz) - March 6, 2015

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