FDA-Approved aBLAs

# Biosimilar Applicant Reference Product aBLA Approval US Launch? Pending BPCIA Litigation?
1 ZARXIO® (filgrastim-sndz) Sandoz NEUPOGEN® Mar. 6, 2015 Sept. 3, 2015 Amgen v. Sandoz
2 INFLECTRA® (infliximab-dyyb) Celltrion REMICADE® Apr. 5, 2016 Late 2016 Janssen v. Celltrion
3 ERELZI® (etanercept-szzs) Sandoz ENBREL® Aug. 30, 2016 No Immunex v. Sandoz
4 AMJEVITA® (adalimumab-atto) Amgen HUMIRA® Sept. 23, 2016 No AbbVie v. Amgen (settled)
5 RENFLEXIS® (infliximab-abda) Samsung Bioepis REMICADE® Apr. 21, 2017 July 2017 Janssen v. Samsung Bioepis
6 CYLTEZO® (adalimumab-adbm) Boehringer Ingelheim HUMIRA® Aug. 26, 2017 No AbbVie v. BI
7 MVASI® (bevacizumab-awwb) Amgen AVASTIN® Sept. 14, 2017 No Genentech v. Amgen

Last updated: Oct. 17, 2017

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