FDA Approvals

# Biosimilar Applicant Reference Product aBLA Approval US Launch Related 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 July 19, 2019 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 Nov. 12, 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
13 HYRIMOZ (adalimumab-adaz) Sandoz HUMIRA [#3] Oct. 31, 2018 AbbVie v. Sandoz
14 UDENYCA (pegfilgrastim-cbqv) Coherus NEULASTA [#2] Nov. 2, 2018 Jan. 3, 2019 Amgen v. Coherus
15 TRUXIMA (rituximab-abbs) Celltrion RITUXAN [#1] Nov. 28, 2018 Genentech v. Celltrion
16 HERZUMA (trastuzumab-pkrb) Celltrion HERCEPTIN [#2] Dec. 14, 2018 Genentech v. Celltrion
17 ONTRUZANT (trastuzumab-dttb) Samsung Bioepis HERCEPTIN [#3] Jan. 18, 2019 Genentech v. Samsung Bioepis
18 TRAZIMERA (trastuzumab-qyyp) Pfizer HERCEPTIN [#4] Mar. 11, 2019 Genentech v. Pfizer
19 ETICOVO (etanercept-ykro) Samsung Bioepis ENBREL [#2] Apr. 25, 2019 Immunex v. Samsung Bioepis
20 KANJINTI (trastuzumab-anns) Amgen HERCEPTIN [#5] June 13, 2019 July 19, 2019 Genentech v. Amgen
21 ZIRABEV(bevacizumab-bvzr) Pfizer AVASTIN [#2] June 28, 2019 Genentech v. Pfizer
22 RUXIENCE(rituximab-pvvr) Pfizer RITUXAN [#2] July 23, 2019 None
23 HADLIMA(adalimumab-bwwd) Samsung Bioepis HUMIRA [#4] July 23, 2019 None
24 ZIEXTENZO(pegfilgrastim-bmez) Sandoz NEULASTA [#3] Nov. 4, 2019 Amgen v. Sandoz

Last updated: November 5, 2019

This page is maintained by Joshua Whitehill.