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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 | |||
| Yusimry (adalimumab-aqvh) | Dec-21 | |||
| LANTUS (INSULIN GLARGINE) | ||||
| Rezvoglar (insuline glargine-aglr) | Dec-21 | |||
| Semglee (insulin glargine-yfgn) | Jul-21 | Nov-21 | ||
| LUCENTIS (RANIBIZUMAB) | ||||
| Byooviz (ranibizumab-nuna) | Sept-21 | |||
| NEULASTA (PEGFILGRASTIM) | ||||
| Fulphila (pegfilgrastim-jmdb) | Jun-18 | Jun-18 | ||
| Nyvepria (pegfilgrastim-apgf) | Jun-20 | Dec-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 | Jul-20 | ||
| RITUXAN (RITUXIMAB) | ||||
| Truxima (rituximab-abbs) | Nov-18 | Nov-19 | ||
| Ruxience (rituximab-pvvr) | Jul-19 | Feb-20 | ||
| Riabni (rituximab-arrx) | Dec-20 | Jan-21 | ||
| Total: 33 approved, 21 launched | *As of December 2021 | |||
| 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:
February 14-16, 2022 | Orlando, Florida
Access! brings together policymakers, influential speakers and industry leaders to chart the future of generics and biosimilars. This year, we're pleased to be meeting in person for the first time since 2019! Sign up before December 31, 2021 to receive $500 off your full-pass registration.
