Table 1.
FDA-approved biosimilars for TNF-α inhibitor agents and rituximab
| Name | Manufacturer | FDA approval | US launch |
|---|---|---|---|
| Infliximab (Remicade®) biosimilars | |||
| Inflectra® (infliximab-dyyb) | Pfizer, Inc. | Apr 2016 | Dec 2016 |
| Renflexis® (infliximab-abda) | Merck & Co., Inc. | Apr 2017 | Jul 2017 |
| Ixifi™ (infliximab-qbtx) | Pfizer, Inc. | Dec 2017 | (Will not be marketed in USA) |
| Avsola™ (infliximab-axxq) | Amgen, Inc | Dec 2019 | Jul 2020 |
| Adalimumab (Humira®) biosimilars | |||
| Amjevita™ (adalimumab-atto) | Amgen, Inc. | Sep 2016 | Not yet marketed |
| Cyltezo™ (adalimumab-adbm) | Boehringer Ingelheim Pharmaceuticals, Inc. | Aug 2017 | Not yet marketed |
| Hyrimoz™ (adalimumab-adaz) | Sandoz, Inc. | Oct 2018 | Not yet marketed |
| Hadlima™ (adalimumab-bwwd) | Samsung Bioepis | Jul 2019 | Not yet marketed |
| Abrilada™ (adalimumab-afzb) | Pfizer, Inc. | Nov 2019 | Not yet marketed |
| Etanercept (Enbrel®) biosimilars | |||
| Erelzi® (etanercept-szzs) | Sandoz, Inc. | Aug 2016 | Not yet marketed |
| Eticovo™ (etanercept-ykro) | Samsung Bioepis | Apr 2019 | Not yet marketed |
| Rituximab (Rituxan®) biosimilars | |||
| Truxima® (rituximab-abbs) | Teva/Celltrion | Nov 2018 | Not yet marketed |
| Ruxience® (rituximab-pvvr) | Pfizer, Inc. | Jul 2019 | Not yet marketed |