FDA Approvals

# Biosimilar Applicant Reference Product aBLA Approval US Launch Pending BPCIA Litigation?
1 ZARXIO® (filgrastim-sndz) Sandoz NEUPOGEN® [#1] Mar. 6, 2015 Sept. 3, 2015 Amgen v. Sandoz
2 INFLECTRA® (infliximab-dyyb) Celltrion REMICADE® [#1] Apr. 5, 2016 Nov. 21, 2016 Janssen v. Celltrion
3 ERELZI™ (etanercept-szzs) Sandoz ENBREL® [#1] Aug. 30, 2016 Immunex v. Sandoz
4 AMJEVITA™ (adalimumab-atto) Amgen HUMIRA® [#1] Sept. 23, 2016 AbbVie v. Amgen
5 RENFLEXIS® (infliximab-abda) Samsung Bioepis REMICADE® [#2] Apr. 21, 2017 July 24, 2017 Janssen v. Samsung Bioepis
6 CYLTEZO™ (adalimumab-adbm) Boehringer Ingelheim HUMIRA® [#2] Aug. 26, 2017 AbbVie v. BI
7 MVASI™ (bevacizumab-awwb) Amgen AVASTIN® [#1] Sept. 14, 2017 Genentech v. Amgen
8 OGIVRI™ (trastuzumab-dkst) Mylan HERCEPTIN® [#1] Dec. 1, 2017 None
9 IXIFI™
(infliximab-qbtx)
Pfizer REMICADE® [#3] Dec. 13, 2017 None
10 RETACRIT™ (epoetin alfa-epbx) Hospira EPOGEN®/ PROCRIT® [#1] May 15, 2018 Amgen v. Hospira
11 FULPHILA™ (pegfilgrastim-jmdb) Mylan NEULASTA® [#1] June 4, 2018 July 2018 Amgen v. Mylan
12 NIVESTYM™ (filgrastim-aafi) Pfizer NEUPOGEN® [#2] July 20, 2018 Oct. 1, 2018 Amgen v. Hospira

Last updated: October 11, 2018