FDA Biosimilars Approvals

Thursday April 23, 2020

FDA Biosimilars Approvals

BiosimilarApproved Launched
AVASTIN (BEVACIZUMAB)
Mvasi (bevacizumab-awwb)Sept-17Jul-19
Zirabev (bevacizumab-bvzr)Jun-19Dec-19
ENBREL (ETANERCEPT)
Erelzi (etanercept-szzs)Aug-16
Eticovo (etanercept-ykro)Apr-19
EPOGEN/PROCRIT (EPOETIN ALFA)
Retacrit (epoetinalfa-epbx)May-18Nov-18
HERCEPTIN (TRASTUZUMAB)
Ogivri (trastuzumab-dkst)Dec-17Dec-19
Herzuma (trastuzumab-pkrb)Dec-18Mar-20
Ontruzant (trastuzumab-dttb)Jan-19April-20
Trazimera (trastuzumab-qyyp) Mar-19Feb-20
Kanjinti (trastuzumab-anns)Jun-19Jul-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-18Jun-18
Nyvepria (pegfilgrastim-apgf)Jun-20
Udenyca (pegfilgrastim-cbqv)Nov-18Jan-19
Ziextenzo (pegfilgrastim-bmez)Nov-19Dec-19
NEUPOGEN (FILGRASTIM)
Zarxio (filgrastim-sndz)Mar-15Sep-15
Nivestym (filgrastim-aafi) Jul-18Oct-18
REMICADE (INFLIXIMAB)
Inflectra (infliximab-dyyb)Apr-16Nov-16
Renflexis (infliximab-abda)Apr-17Jul-17
Ixifi (infliximab-qbtx)Dec-17
Avsola (infliximab-axxq)Dec-19
RITUXAN (RITUXIMAB)
Truxima (rituximab-abbs)Nov-18Nov-19
Ruxience (rituximab-pvvr)Jul-19Feb-20
Total: 28 approved, 17 launched*As of April 2020
Source: FDA

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