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
Riabni (rituximab-arrx)Dec-20
Total: 29 approved, 17 launched*As of December 2020
Source: FDA

Stay Informed

Subscribe for Updates

Receive our monthly Biosimilars Bulletin and other important updates on biosimilars in the U.S.

  • This field is for validation purposes and should be left unchanged.

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.

LEARN MORE

Recent Tweets