Table 2. US Food and Drug Administration Approvals of Biosimilar Biologics and Their Reference Products.
| Therapeutic category/brand namea | Chemical name | Reference product | Approval date | Launched?b |
|---|---|---|---|---|
| Anti-TNF | ||||
| Amjevita16,17 | adalimumab-atto | Humira | 9/23/2016 | No |
| Cyltezo18 | adalimumab-adbm | Humira | 8/25/2017 | No |
| Hadlima19 | adalimumab-bwwd | Humira | 7/23/2019 | No |
| Hyrimoz20 | adalimumab-adaz | Humira | 10/20/2018 | No |
| Erelzi21 | etanercept-szzs | Enbrel | 8/30/2016 | No |
| Eticovo22 | etanercept-ykro | Enbrel | 4/25/2019 | No |
| Renflexis23 | infliximab-abda | Remicade | 4/21/2017 | Yes |
| Inflectra24 | infliximab-dyyb | Remicade | 4/5/2016 | Yes |
| Ixifi25 | infliximab-qbtx | Remicade | 12/13/2017 | No |
| Hematopoiesis | ||||
| Nivestym26,27,28 | filgrastim-aafi | Neupogen | 7/20/2018 | Yes |
| Zarxio29 | filgrastim-sndz | Neupogen | 3/6/2015 | Yes |
| Udenyca30,31 | pegfilgrastim-cbqv | Neulasta | 11/2/2018 | Yes |
| Fulphila32 | pegfilgrastim-jmdb | Neulasta | 6/4/2018 | Yes |
| Retacrit33,34 | epoetin alfa-epbx | Epogen | 5/15/2018 | Yes |
| Oncology | ||||
| Ontruzant35 | trastuzumab-dttb | Herceptin | 1/18/2019 | No |
| Kanjinti36 | trastuzumab-anns | Herceptin | 6/13/2019 | Yes |
| Ogivri37 | trastuzumab-dkst | Herceptin | 12/1/2017 | Yes |
| Herzuma38 | trastuzumab-pkrb | Herceptin | 12/14/2018 | Yes |
| Trazimera39 | trastuzumab-qyyp | Herceptin | 3/11/2019 | No |
| Mvasi40 | bevacizumab-awwb | Avastin | 9/14/2017 | Yes |
| Zirabev41 | bevacizumab-bvzr | Avastin | 6/27/2019 | No |
| Truxima42,43 | rituximab-abbs | Rituxan | 11/28/2018 | Yes |
| Ruxience44 | rituximab-pvvr | Rituxan | 7/23/2019 | No |
Abbreviation: TNF, tumor necrosis factor.
a
Nivestym and Udenyca approved with phase 1 trials only.
b
As of March 1, 2020.