Biosimilar approval and launch status in US

 

Total count of FDA-approved biosimilars: 38
Total count of launched biosimilars: 22

 

  Biosimilar name (brand) Biosimilar name (generic) Biosimilar manufacturer  Biosimilar Marketer Approval date Launch date  Reference name (generic) Reference name (brand) Reference manufacturer
 1   GRAVIX®*  tbo-filgrastim  Teva  Teva  Aug 29, 2012   Nov 1, 2013  filgrastim  NEUPOGEN®  Amgen
 2  ZARXIO®  filgrastim-sndz  Sandoz (Novartis)  Sandoz (Novartis)  Mar 6, 2015  Sep 3, 2015   filgrastim  NEUPOGEN®  Amgen
 3  INFLECTRA®  infliximab-dyyb  Pfizer  Merck  Apr 5, 2016  Nov 28, 2016  infliximab  REMICADE®  Janssen
 4  RENFLEXIS®  infliximab-abda  Samsung Bioepis  Merck  Apr 21, 2017  Jul 24, 2017  infliximab  REMICADE®  Janssen
 5  Fulphila®  pegfilgrastim-jmdb  Viatris and Biocon  Viatris  Jun 4, 2018  Jul 26, 2018  pegfilgrastim  Neulasta®  Amgen
 6  Nivestym®  filgrastim-aafi  Pfizer  Pfizer Jul 20, 2018 Oct 1, 2018  filgrastim  NEUPOGEN®  Amgen
 7  RETACRIT®  epoetin alfa-epbx  Pfizer  Pfizer  May 15, 2018  Nov 12, 2018  epoetin alfa  EPOGEN® / PROCRIT®  Amgen / J&J
 8  UDENYCA®  pegfilgrastim-cbqv  Coherus BioSciences  Coherus BioSciences  Nov 2, 2018  Jan 3, 2019  pegfilgrastim  Neulasta®  Amgen
 9  MVASI®  bevacizumab-awwb  Amgen  Amgen  Sep 14, 2017  Jul 18, 2019  bevacizumab  Avastin®  Genentech
 10  KANJINTI®  trastuzumab-anns  Amgen  Amgen  Jun 13, 2019  Jul 18, 2019  trastuzumab  Herceptin®  Genentech
 11 TRUXIMA®  rituximab-abbs  Celltrion  Teva  Nov 28, 2018  Nov 11, 2019  rituximab  RITUXAN®  Genentech
 12  ZIEXTENZO®  pegfilgrastim-bmez  Sandoz (Novartis)  Sandoz (Novartis)  Nov 4, 2019  Nov 15, 2019  pegfilgrastim  Neulasta®  Amgen
 13  Ogivri®  trastuzumab-dkst  Viatris and Biocon  Viatris  Dec 1, 2017  Dec 2, 2019  trastuzumab  Herceptin®  Genentech
 14  ZIRABEV™  bevacizumab-bvzr  Pfizer  Pfizer  Jun 28, 2019  Dec 31, 2019  bevacizumab  Avastin®  Genentech
 15  RUXIENCE™  rituximab-pvvr  Pfizer  Pfizer  Jul 23, 2019  Jan 23, 2020  rituximab  RITUXAN®  Genentech
 16  TRAZIMERA™  trastuzumab-qyyp  Pfizer  Pfizer  Mar 11, 2019  Feb 15, 2020  trastuzumab  Herceptin®  Genentech
 17  HERZUMA® trastuzumab-pkrb  Celltrion  Teva  Dec 14, 2018  Mar 16, 2020  trastuzumab  Herceptin®  Genentech
 18  ONTRUZANT®  trastuzumab-dttb  Samsung Bioepis  Merck  Jan 18, 2019  Apr 15, 2020  trastuzumab  Herceptin®  Genentech
 19  AVSOLA®  infliximab-axxq  Amgen  Amgen  Dec 6, 2019 Jul 6, 2020  infliximab  REMICADE®  Janssen
 20   NYVEPRIA™    pegfilgrastim-apgf  Pfizer  Pfizer  Jun 10, 2020  Dec 15, 2020  pegfilgrastim  Neulasta®  Amgen
 21  RIABNI™  rituximab-arrx  Amgen  Amgen  Dec 17, 2020  Jan 6, 2021  rituximab  RITUXAN®  Genentech
 22  Erelzi®  etanercept-szzs  Sandoz (Novartis)  Sandoz (Novartis)  Aug 30, 2016    etanercept  Enbrel®  Amgen
 23  AMJEVITA™  adalimumab-atto  Amgen  Amgen  Sep 23, 2016  Jan 31, 2023†   adalimumab  HUMIRA®  AbbVie
 24  HADLIMA™   adalimumab-bwwd  Samsung Bioepis  Merck  Jul 23, 2019  Jun 30, 2023   adalimumab  HUMIRA®  AbbVie
 25  CYLTEZO™  adalimumab-adbm  Boehringer Ingelheim  Boehringer Ingelheim  Biosimilar: Aug 25, 2017
Interchangeable: Oct 18, 2021 
 Jul 1, 2023†   adalimumab  HUMIRA®  AbbVie
 26  HULIO®   adalimumab-fkjp  Viatris  Viatris  Jul 6, 2020 Jul 31, 2023   adalimumab  HUMIRA®  AbbVie
 27  Hyrimoz®  adalimumab-adaz  Sandoz (Novartis)  Sandoz (Novartis)  Oct 30, 2018  Sep 30, 2023†   adalimumab  HUMIRA®  AbbVie
 28  ABRILADA™  adalimumab-afzb  Pfizer  Pfizer  Nov 15, 2019  Nov 20, 2023   adalimumab  HUMIRA®  AbbVie
 29  Eticovo™  etanercept-ykro  Samsung Bioepis  Samsung Bioepis  Apr 25, 2019    etanercept  Enbrel®  Amgen
 30  IXIFI™  infliximab-qbtx  Pfizer  Pfizer  Dec 13, 2017  Will not be marketed in the US due to INFLECTRA  infliximab  REMICADE®  Janssen
 31  SEMGLEE®‡  insulin glargine-yfgn  Biocon  Viatris  Jul 28, 2021  Nov 16, 2021  insulin glargine  LANTUS®  Sanofi
 32  BYOOVIZ™  (Samsung Bioepis/Biogen)   ranibizumab-nuna  Samsung Bioepis  Biogen  Sep 17, 2021  Jun 2, 2022  ranibizumab   LUCENTIS®  Genentech
 33  YUSIMRY™  adalimumab-aqvh  Coherus BioSciences  Coherus BioSciences  Dec 17, 2021  Expected July 1, 2023  adalimumab  HUMIRA®  AbbVie
 34  RELEUKO™  filgrastim-ayow  Kashiv BioSciences  Amneal Pharmaceuticals  Feb 25, 2022 Expected Q3 2022  filgrastim  NEUPOGEN®  Amgen
 35  REZVOGLAR™  insulin glargine-aglr  Eli Lilly  Eli Lilly  Dec 17, 2021   insulin glargine  LANTUS®  Sanofi
 36  ALYMSYS®  bevacizumab-maly  mAbxience  Amneal Pharmaceuticals  Apr 13, 2022    bevacizumab  AVASTIN®

Genentech

 37  FYLNETRA®  pegfilgrastim-pbbk  Kashiv BioSciences  Amneal Pharmaceuticals  May 26, 2022  Expected 2H 2022  pegfilgrastim  NEULASTA®

Amgen

 38  CIMERLI™  ranibizumab-eqrn   Coherus BioSciences   Coherus BioSciences  Aug 2, 2022 Expected Oct 2022  ranibizumab  LUCENTIS®   Genentech
 39  STIMUFEND®   pegfilgrastim-fpgk   Fresenius Kabi  Fresenius Kabi  Sep 6, 2022  Early 2023  pegfilgrastim  NEULASTA®   Amgen

* GRAVIX is not a biosimilar. It was approved under a stand-alone Biologics License Application, which was submitted to the FDA before enactment of the biosimilar approval pathway.

Anticipated US launch date - actual launch date may vary. 

Interchangeable