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FDA Biosimilars Approvals
FDA Biosimilars Approvals
| Biosimilar | Approved | Launched | ||
|---|---|---|---|---|
| AVASTIN (BEVACIZUMAB) | ||||
| Mvasi (bevacizumab-awwb) | Sept-17 | Jul-19 | ||
| Zirabev (bevacizumab-bvzr) | Jun-19 | Dec-19 | ||
| ENBREL (ETANERCEPT) | ||||
| Erelzi (etanercept-szzs) | Aug-16 | |||
| Eticovo (etanercept-ykro) | Apr-19 | |||
| EPOGEN/PROCRIT (EPOETIN ALFA) | ||||
| Retacrit (epoetinalfa-epbx) | May-18 | Nov-18 | ||
| HERCEPTIN (TRASTUZUMAB) | ||||
| Ogivri (trastuzumab-dkst) | Dec-17 | Dec-19 | ||
| Herzuma (trastuzumab-pkrb) | Dec-18 | Mar-20 | ||
| Ontruzant (trastuzumab-dttb) | Jan-19 | April-20 | ||
| Trazimera (trastuzumab-qyyp) | Mar-19 | Feb-20 | ||
| Kanjinti (trastuzumab-anns) | Jun-19 | Jul-19 | ||
| HUMIRA (ADALIMUMAB) | ||||
| Amjevita (adalimumab-atto) | Sept-16 | |||
| Cyltezo (adalimumab-adbm) | Sept-16 | |||
| Hyrimoz (adalimumab-adaz) | Oct-18 | |||
| Hadlima (adalimumab-bwwd) | Jul-19 | |||
| Abrilada (adalimumab-afzb) | Nov-19 | |||
| Hulio (adalimumab-fkjp) | Jul-20 | |||
| NEULASTA (PEGFILGRASTIM) | ||||
| Fulphila (pegfilgrastim-jmdb) | Jun-18 | Jun-18 | ||
| Nyvepria (pegfilgrastim-apgf) | Jun-20 | |||
| Udenyca (pegfilgrastim-cbqv) | Nov-18 | Jan-19 | ||
| Ziextenzo (pegfilgrastim-bmez) | Nov-19 | Dec-19 | ||
| NEUPOGEN (FILGRASTIM) | ||||
| Zarxio (filgrastim-sndz) | Mar-15 | Sep-15 | ||
| Nivestym (filgrastim-aafi) | Jul-18 | Oct-18 | ||
| REMICADE (INFLIXIMAB) | ||||
| Inflectra (infliximab-dyyb) | Apr-16 | Nov-16 | ||
| Renflexis (infliximab-abda) | Apr-17 | Jul-17 | ||
| Ixifi (infliximab-qbtx) | Dec-17 | |||
| Avsola (infliximab-axxq) | Dec-19 | |||
| RITUXAN (RITUXIMAB) | ||||
| Truxima (rituximab-abbs) | Nov-18 | Nov-19 | ||
| Ruxience (rituximab-pvvr) | Jul-19 | Feb-20 | ||
| Riabni (rituximab-arrx) | Dec-20 | |||
| Total: 29 approved, 17 launched | *As of December 2020 | |||
| Source: FDA | ||||
Get Involved
The Council is involved in a number of events that focus on advancing biosimilars in the United States. Click on one below to learn more:
Access! 2021 - AAM Annual Meeting
Join us May 26-27, 2021 for the industry's largest virtual conference. Access! convenes business leaders in the generics and biosimilars industry to get the inspiration, ideas and connections they need to drive their business forward.
