Pending U.S. District Court BPCIA Litigations
| Litigation | Accused Biosimilar [status] |
Reference Product |
Complaint Filed | Status/Outcome | |
| District Court | Appeal | ||||
| Genentech, Inc. v. Tanvex Biopharma USA, Inc. et al.
No. 1:22-CV-0809 (S.D. Cal.) |
TX05 (trastuzumab) [not approved] |
HERCEPTIN | June 2, 2022 | Pending | |
| Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. No. 1:22-cv-00061 (D. Del.) |
M710 (aflibercept) [not approved] |
EYLEA | August 2, 2022 | Pending | |
| Biogen Inc. et al. v. Sandoz Inc. et al. No. 1:22-cv–1190 (D. Del.) |
PB006 (natalizumab) [not approved] |
TYSABRI | Sept. 19, 2022 | Pending | |
| Janssen Biotech, Inc. v. Amgen Inc., No. 1:22-cv-01549 (D. Del.) | ABP 654 (ustekinumab) [not approved] |
STELARA | November 29, 2022 | 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 |
| 26 | Genentech v. Centus, No. 20-361 (E.D. Tex.) |
FKB238 (bevacizumab biosimilar) [not approved] |
AVASTIN [litigation #4] |
November 12, 2020 | Settled | n/a |
| 27 | Amgen v. Hospira, Nos. 18-1064, 20-561 (D. Del.) |
NIVESTYM (filgrastim-aafi) [approved] [launched] |
NEUPOGEN [litigation #4] |
July 18, 2018 | Dismissed with prejudice | n/a |
| 28 | Immunex v. Samsung Bioepis, No. 19-11755 (D.N.J.) |
ETICOVO (etanercept-ykro) [approved] |
ENBREL [litigation #2] |
Apr. 29, 2019 | Final Judgment and Order of Permanent Injunction | n/a |
| 29 | Genentech v. Samsung Bioepis, No. 20-859 (D. Del.) |
SB8 (bevacizumab biosimilar) [not approved] |
AVASTIN [litigation #3] |
June 28, 2020 | Settled | n/a |
| 29 | AbbVie v. Alvotech,
No. 21-2258, 21-2899 (N.D. Ill.) |
AVT02 (adalimumab biosimilar) [not approved] |
HUMIRA [litigation #4] |
April 27, 2021, May 28, 2021 | Settled | |
| 30 | Amgen v. Hospira, No. 20-201 (D. Del.) |
NYVEPRIA (pegfilgrastim-apgf) [approved] |
NEULASTA [litigation #5] |
Feb. 11, 2020 | Settled | |
Last updated: December 12, 2022