Biosimilar approval and launch status in US
Total count of FDA-approved biosimilars: 39
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 |
| 40 | VEGZELMA® | bevacizumab-adcd | Celltrion | Sep 27, 2022 | bevacizumab | AVASTIN® | Genentech |
* 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