FDA Biosimilar 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 | Apr-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 | ||
Total: 28 approved, 17 launched | *As of April 2020 | |||
Source: FDA |