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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 | |||
| LANTUS (INSULIN GLARGINE) | ||||
| Semglee (insulin glargine-yfgn) | Jul-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: 31 approved, 20 launched | *As of September 2021 | |||
| Source: FDA | ||||
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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:
GRx+Biosims 2021 | Virtual Conference
Join us on November 8-10. GRx+Biosims 2021 is the premier scientific and regulatory event for the U.S. generics and biosimilars industry.
