BPCIA Litigations

Pending U.S. District Court BPCIA Litigations

Litigation Accused Biosimilar
[status] 		Reference Product
 Complaint Filed Status/Outcome
District Court Appeal
Amgen v. Hospira,
Nos. 18-1064, 20-561 (D. Del.)
NIVESTYM (filgrastim-aafi)
[approved] [launched]		 NEUPOGEN
[litigation #4]		 July 18, 2018 Pending – jury trial scheduled for May 17, 2021
Immunex v. Samsung Bioepis,
No. 19-11755 (D.N.J.)		 ETICOVO (etanercept-ykro)
[approved]		 ENBREL
[litigation #2]		 Apr. 29, 2019 Pending (administratively stayed)
Amgen v. Hospira,
No. 20-201 (D. Del.)		 NYVEPRIA (pegfilgrastim-apgf)
[approved]		 NEULASTA
[litigation #5]		 Feb. 11, 2020 Pending
Genentech v. Samsung Bioepis,
No. 20-859 (D. Del.)		 SB8 (bevacizumab biosimilar)
[not approved]		 AVASTIN
[litigation #3]		 June 28, 2020 Pending
 Genentech v. Centus,
No. 20-361 (E.D. Tex.)		 FKB238 (bevacizumab biosimilar)
[not approved]		 AVASTIN
[litigation #4]		 November 12, 2020 Pending

Resolved U.S. District Court BPCIA Litigations

# Litigation Accused Biosimilar
[status] 		Reference Product
 Complaint Filed Status/Outcome
District Court Appeal
1 Amgen v. Sandoz,
No. 14-474 (N.D. Cal.)
[consolidated with #7 below]		 ZARXIO (filgrastim-sndz)
[approved; launched]		 NEUPOGEN
[litigation #1]		 Oct. 24, 2014 Summary judgment of non-infringement in favor of Sandoz Affirmed by Fed. Cir.; opinion modified on panel rehearing
2 Janssen v. Celltrion,
No. 17-11008 (D. Mass.)		 INFLECTRA (infliximab-dyyb)
[approved; launched]		 REMICADE
[litigation #1]		 Mar. 6, 2015 (refiled May 31, 2017) Summary judgment of invalidity as to ’471 patent; summary judgment of non-infringement as to ’083 patent, subject to any appeal Fed. Cir. appeal of ’471 judgment dismissed, and appeal of ’083 judgment affirmed, both in favor of Celltrion
3 Amgen v. Apotex,
No. 15-61631 (S.D. Fla.)
[consolidated with #5 below]		 Lapelga (pegfilgrastim biosimilar)
[not approved]		 NEULASTA
[litigation #1]		 Aug. 6, 2015 Judgment of non-infringement in favor of Apotex Affirmed by Fed. Cir.
4 Amgen v. Hospira,
No. 15-839 (D. Del.)		 RETACRIT (epoetin alfa-epbx)
[approved; launched]		 EPOGEN/ PROCRIT
[litigation #1]		 Sept. 18, 2015 Jury found infringement and awarded Amgen $70M; Hospira’s post-trial motions denied Affirmed by Fed. Cir.; rehearing denied
5 Amgen v. Apotex,
No. 15-62081 (S.D. Fla.)
[consolidated with #3 above]		 Grastofil (filgrastim biosimilar)
[not approved]		 NEUPOGEN
[litigation #2]		 Oct. 2, 2015 Judgment of non-infringement in favor of Apotex Affirmed by Fed. Cir.
6 Immunex v. Sandoz,
No. 16-01118 (D.N.J.)		 ERELZI (etanercept-szzs)
[approved]		 ENBREL
[litigation #1]		 Feb. 26, 2016 Judgment of infringement and no invalidity in favor of Immunex Affirmed by Fed. Cir.
7 Amgen v. Sandoz,
No. 16-2581 (N.D. Cal.)
[consolidated with #1 above]		 ZIEXTENZO (pegfilgrastim-bmez)
[approved; launched]		 NEULASTA
[litigation #2]		 Mar. 4, 2016 Summary judgment of non-infringement in favor of Sandoz Affirmed by Fed. Cir.; opinion modified on panel rehearing
8 AbbVie v. Amgen,
No. 16-666 (D. Del.)		 AMJEVITA (adalimumab-atto)
[approved]		 HUMIRA
[litigation #1]		 Aug. 4, 2016 Settled n/a
9 Amgen v. Coherus,
No. 17-546 (D. Del.)		 UDENYCA (pegfilgrastim-cbqv)
[approved; launched]		 NEULASTA
[litigation #3]		 May 10, 2017 Motion to dismiss granted Affirmed by Fed. Cir.
10 Janssen v. Samsung Bioepis,
No. 17-3524 (D.N.J.)		 RENFLEXIS (infliximab-abda)
[approved, launched]		 REMICADE
[litigation #2]		 May 17, 2017 Voluntarily dismissed with prejudice n/a
11 AbbVie v. Boehringer Ingelheim,
No. 17-1065 (D. Del.)		 CYLTEZO (adalimumab-adbm)
[approved]		 HUMIRA
[litigation #2]		 Aug. 2, 2017 Settled n/a
12 Amgen v. Mylan,
No. 17-1235 (W.D. Pa.)		 FULPHILA (pegfilgrastim-jmdb)
[approved; launched]		 NEULASTA
[litigation #4]		 Sept. 22, 2017 Stipulation of non-infringement n/a
13 Genentech v. Amgen,
Nos. 17-1407, -1471, 19-602 (D. Del.)		 MVASI (bevacizumab-awwb)
[approved; launched]		 AVASTIN
[litigation #1]		 Oct. 6, 2017 Settled Denial of PI affirmed on interlocutory appeal
14 Genentech v. Pfizer,
No. 17-1672 (D. Del.)		 TRAZIMERA (trastuzumab-qyyp)
[approved; launched]		 HERCEPTIN
[litigation #1]		 Nov. 17, 2017 Settled n/a
15 Genentech v. Sandoz,
No. 17-13507 (D.N.J.)		 GP2013 (rituximab biosimilar)
[not approved]		 RITUXAN
[litigation #1]		 Dec. 21, 2017 Settled n/a
16 Genentech v. Celltrion,
Nos. 18-095, -1025 (D. Del.)		 HERZUMA (trastuzumab-pkrb)
[approved; launched]		 HERCEPTIN
[litigation #2]		 Jan. 12, 2018 Settled n/a
17 Genentech v. Celltrion,
Nos. 18-574, -11553 (D.N.J.)		 TRUXIMA (rituximab-abbs)
[approved; launched]		 RITUXAN
[litigation #2]		 Jan. 12, 2018 Settled n/a
18 Amgen v. Kashiv (formerly Adello),
No. 18-3347 (D.N.J.)		 TPI G-CSF (filgrastim biosimilar)
[not approved]		 NEUPOGEN
[litigation #3]		 Mar. 8, 2018 Settled n/a
19 Genentech v. Amgen,
No. 18-924 (D. Del.)		 KANJINTI (trastuzumab-anns)
[approved; launched]		 HERCEPTIN
[litigation #3]		 June 21, 2018 Settled Denial of PI affirmed on interlocutory appeal
21
 Amgen v. Accord (previously Apotex),
No. 18-61828 (S.D. Fla.)
[follow-on case to #3 & 5 above]		 Lapelga (pegfilgrastim biosimilar)
[not approved];
Grastofil (filgrastim biosimilar)
[not approved]		 NEULASTA
[litigation #1]; NEUPOGEN
[litigation #2]		 Aug. 7, 2018 Settled n/a
22
 AbbVie v. Sandoz,
No. 18-12668 (D.N.J.)		 HYRIMOZ (adalimumab-adaz)
[approved]		 HUMIRA
[litigation #3]		 Aug. 10, 2018 Settled n/a
23
 Genentech v. Samsung Bioepis,
No. 18-1363 (D. Del.)		 ONTRUZANT (trastuzumab-dttb)
[approved; launched]		 HERCEPTIN
[litigation #4]		 Sept. 4, 2018 Settled n/a
24
 Genentech v. Pfizer,
No. 19-638 (D. Del.)		 ZIRABEV (bevacizumab-bvzr)
[approved; launched]		 AVASTIN
[litigation #2]		 Apr. 5, 2019 Settled n/a
25
 Amgen v. Tanvex,
No. 19-1374 (S.D. Cal.)		 TX-01 (filgrastim biosimilar)
[not approved]		 NEUPOGEN
[litigation #5]		 July 23, 2019 Settled n/a

Last updated: December 9, 2020

This page is maintained by Naomi Birbach.