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What biosimilars have been approved in the United States?

Medically reviewed by Judith Stewart, BPharm. Last updated on July 16, 2025.

Official Answer by Drugs.com

Is there a list of all biosimilars approved in the United States?

There have been 72 biosimilars approved by the U.S. Food and Drug Administration (FDA). The most recent biosimilar approval was Kirsty (insulin aspart-xjhz) on July 15, 2025.

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)

Actemra (tocilizumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Avtozma
(tocilizumab-anoh)
Interchangeable (certain presentations) Celltrion, Inc. January 24, 2025
Tyenne
(tocilizumab-aazg)
Biosimilar Fresenius Kabi USA, LLC March 5, 2024
Tofidence
(tocilizumab-bavi)
Biosimilar Biogen Inc. September 29, 2023
Avastin (bevacizumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Jobevne
(bevacizumab-nwgd)
Biosimilar Biocon Biologics Ltd. April 9, 2025
Avzivi
(bevacizumab-tnjn)
Biosimilar Bio-Thera Solutions, Ltd. December 6, 2023
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
Eylea (aflibercept) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Pavblu
(aflibercept-ayyh)
Biosimilar Amgen, Inc. August 23, 2024
Enzeevu
(aflibercept-abzv)
Biosimilar Sandoz Inc. August 9, 2024
Ahzantive
(aflibercept-mrbb)
Biosimilar Formycon AG June 28, 2024
Opuviz
(aflibercept-yszy)
Interchangeable Samsung Bioepis Co., Ltd. May 20, 2024
Yesafili
(aflibercept-jbvf)
Interchangeable Biocon Biologics Inc. May 20, 2024
Herceptin (trastuzumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Hercessi
(trastuzumab-strf)
Biosimilar Accord BioPharma Inc. April 26, 2024
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
Simlandi
(adalimumab-ryvk)
Interchangeable Alvotech and Teva Pharmaceutical Industries Ltd. February 23, 2024
Yuflyma
(adalimumab-aaty)
Interchangeable Celltrion, Inc. May 23, 2023
Idacio
(adalimumab-aacf)
Biosimilar Fresenius Kabi USA, LLC December 13, 2022
Yusimry
(adalimumab-aqvh)
Biosimilar Coherus BioSciences, Inc. December 17, 2021
Hulio
(adalimumab-fkjp)
Interchangeable Mylan Pharmaceuticals Inc. July 6, 2020
Abrilada
(adalimumab-afzb)
Interchangeable Pfizer Inc. November 15, 2019
Hadlima
(adalimumab-bwwd)
Interchangeable Samsung Bioepis Co., Ltd. July 23, 2019
Hyrimoz
(adalimumab-adaz)
Interchangeable (certain presentations) Sandoz Inc. October 30, 2018
Cyltezo
(adalimumab-adbm)
Interchangeable (certain presentations) Boehringer Ingelheim Pharmaceuticals, Inc. August 25, 2017
Amjevita
(adalimumab-atto)
Interchangeable (certain presentations) 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)
Interchangeable 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
Nypozi
(filgrastim-txid)
Biosimilar Tanvex BioPharma USA, Inc. June 28, 2024
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
NovoLog (insulin aspart) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Kirsty
(insulin aspart-xjhz)
Interchangeable Biocon Biologics Inc. July 15, 2025
Merilog
(insulin aspart-szjj)
Biosimilar Sanofi-Aventis U.S. LLC February 14, 2025
Prolia (denosumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Conexxence
(denosumab-bnht)
Biosimilar Fresenius Kabi USA, LLC March 25, 2025
Stoboclo
(denosumab-bmwo)
Biosimilar Celltrion, Inc. February 28, 2025
Ospomyv
(denosumab-dssb)
Biosimilar Samsung Bioepis Co., Ltd. February 13, 2025
Jubbonti
(denosumab-bbdz)
Interchangeable Sandoz Inc. March 5, 2024
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
Soliris (eculizumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Epysqli
(eculizumab-aagh)
Biosimilar Samsung Bioepis Co., Ltd. July 19, 2024
Bkemv
(eculizumab-aeeb)
Interchangeable Amgen Inc. May 28, 2024
Stelara (ustekinumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Starjemza
(ustekinumab-hmny)
Interchangeable Bio-Thera Solutions, Ltd. May 22, 2025
Steqeyma
(ustekinumab-stba)
Interchangeable Celltrion, Inc. December 17, 2024
Yesintek
(ustekinumab-kfce)
Interchangeable Biocon Biologics Ltd. November 29, 2024
Imuldosa
(ustekinumab-srlf)
Biosimilar Accord BioPharma, Inc. October 10, 2024
Otulfi
(ustekinumab-aauz)
Interchangeable Fresenius Kabi and Formycon AG September 27, 2024
Pyzchiva
(ustekinumab-ttwe)
Interchangeable Sandoz and Samsung Bioepis Co., Ltd. June 28, 2024
Selarsdi
(ustekinumab-aekn)
Interchangeable Alvotech and Teva Pharmaceutical Industries Ltd. April 16, 2024
Wezlana
(ustekinumab-auub)
Interchangeable (certain presentations) Amgen Inc. October 31, 2023
Tysabri (natalizumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Tyruko
(natalizumab-sztn)
Biosimilar Sandoz Inc. August 24, 2023
Xgeva (denosumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Bomyntra
(denosumab-bnht)
Biosimilar Fresenius Kabi USA, LLC March 25, 2025
Osenvelt
(denosumab-bmwo)
Biosimilar Celltrion, Inc. February 28, 2025
Xbryk
(denosumab-dssb)
Biosimilar Samsung Bioepis Co., Ltd. February 13, 2025
Wyost
(denosumab-bbdz)
Interchangeable Sandoz Inc. March 5, 2024
Xolair (omalizumab) Biosimilars
Name Regulatory Designation Company Name FDA Approved
Omlyclo
(omalizumab-igec)
Interchangeable Celltrion, Inc. March 7, 2025

Related questions

Biosimilars by approval date

  1. Kirsty (insulin aspart-xjhz) - July 15, 2025
  2. Starjemza (ustekinumab-hmny) - May 22, 2025
  3. Jobevne (bevacizumab-nwgd) - April 9, 2025
  4. Conexxence and Bomyntra (denosumab-bnht) - March 25, 2025
  5. Omlyclo (omalizumab-igec) - March 7, 2025
  6. Stoboclo and Osenvelt (denosumab-bmwo) - February 28, 2025
  7. Merilog (insulin aspart-szjj) - February 14, 2025
  8. Ospomyv and Xbryk (denosumab-dssb) - February 13, 2025
  9. Avtozma (tocilizumab-anoh) - January 24, 2025
  10. Steqeyma (ustekinumab-stba) - December 17, 2024
  11. Yesintek (ustekinumab-kfce) - November 29, 2024
  12. Imuldosa (ustekinumab-srlf) - October 10, 2024
  13. Otulfi (ustekinumab-aauz) - September 27, 2024
  14. Pavblu (aflibercept-ayyh) - August 23, 2024
  15. Enzeevu (aflibercept-abzv) - August 9, 2024
  16. Epysqli (eculizumab-aagh) - July 19, 2024
  17. Ahzantive (aflibercept-mrbb) - June 28, 2024
  18. Pyzchiva (ustekinumab-ttwe) - June 28, 2024
  19. Nypozi (filgrastim-txid) - June 28, 2024
  20. Bkemv (eculizumab-aeeb) - May 28, 2024
  21. Yesafili (aflibercept-jbvf) - May 20, 2024
  22. Opuviz (aflibercept-yszy) - May 20, 2024
  23. Hercessi (trastuzumab-strf) - April 25, 2024
  24. Selarsdi (ustekinumab-aekn) - April 16, 2024
  25. Tyenne (tocilizumab-aazg) - March 5, 2024
  26. Jubbonti and Wyost (denosumab-bbdz) - March 5, 2024
  27. Simlandi (adalimumab-ryvk) - February 23, 2024
  28. Avzivi (bevacizumab-tnjn) - December 6, 2023
  29. Wezlana (ustekinumab-auub) - October 31, 2023
  30. Tofidence (tocilizumab-bavi) - September 29, 2023
  31. Tyruko (natalizumab-sztn) - August 24, 2023
  32. Yuflyma (adalimumab-aaty) - May 23, 2023
  33. Idacio (adalimumab-aacf) - December 13, 2022
  34. Vegzelma (bevacizumab-adcd) - September 27, 2022
  35. Stimufend (pegfilgrastim-fpgk) - September 1, 2022
  36. Cimerli (ranibizumab-eqrn) - August 2, 2022
  37. Fylnetra (pegfilgrastim-pbbk) - May 26, 2022
  38. Alymsys (bevacizumab-maly) - April 13, 2022
  39. Releuko (filgrastim-ayow) - February 25, 2022
  40. Yusimry (adalimumab-aqvh) - December 17, 2021
  41. Rezvoglar (insulin glargine-aglr) - December 17, 2021
  42. Byooviz (ranibizumab-nuna) - September 17, 2021
  43. Semglee (insulin glargine-yfgn) - July 28, 2021
  44. Riabni (rituximab-arrx) - December 17, 2020
  45. Hulio (adalimumab-fkjp) - July 6, 2020
  46. Nyvepria (pegfilgrastim-apgf) - June 10, 2020
  47. Avsola (infliximab-axxq) - December 6, 2019
  48. Abrilada (adalimumab-afzb) - November 15, 2019
  49. Ziextenzo (pegfilgrastim-bmez) - November 4, 2019
  50. Hadlima (adalimumab-bwwd) - July 23, 2019
  51. Ruxience (rituximab-pvvr) - July 23, 2019
  52. Zirabev (bevacizumab-bvzr) - June 27, 2019
  53. Kanjinti (trastuzumab-anns) - June 13, 2019
  54. Eticovo (etanercept-ykro) - April 25, 2019
  55. Trazimera (trastuzumab-qyyp) - March 11, 2019
  56. Ontruzant (trastuzumab-dttb) - January 18, 2019
  57. Herzuma (trastuzumab-pkrb) - December 14, 2018
  58. Truxima (rituximab-abbs) - November 28, 2018
  59. Udenyca (pegfilgrastim-cbqv) - November 2, 2018
  60. Hyrimoz (adalimumab-adaz) - October 30, 2018
  61. Nivestym (filgrastim-aafi) - July 20, 2018
  62. Fulphila (pegfilgrastim-jmdb) - June 4, 2018
  63. Retacrit (epoetin alfa-epbx) - May 15, 2018
  64. Ixifi (infliximab-qbtx) - December 13, 2017
  65. Ogivri (trastuzumab-dkst) - December 1, 2017
  66. Mvasi (bevacizumab-awwb) - September 14, 2017
  67. Cyltezo (adalimumab-adbm) - August 25, 2017
  68. Renflexis (infliximab-abda) - April 21, 2017
  69. Amjevita (adalimumab-atto) - September 23, 2016
  70. Erelzi (etanercept-szzs) - August 30, 2016
  71. Inflectra (infliximab-dyyb) - April 5, 2016
  72. Zarxio (filgrastim-sndz) - March 6, 2015

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