The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products. For additional details, please consult the links below or some of our prior BPCIA litigation coverage.
| # | 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, in favor of Celltrion; appeal of ’083 judgment pending |
| 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.; petition for rehearing en banc pending |
| 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 | Pending in 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 | Pending | Interlocutory appeal from denial of PI pending |
| 14 | Genentech v. Pfizer, No. 17-1672 (D. Del.) |
TRAZIMERA (trastuzumab-qyyp) [approved] |
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] |
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 | Pending | Interlocutory appeal from denial of PI pending |
| 20 |
Amgen v. Hospira, No. 18-1064 (D. Del.) |
NIVESTYM (filgrastim-aafi) [approved] [launched] |
NEUPOGEN [litigation #4] |
July 18, 2018 | Pending | |
| 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] |
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 |
Immunex v. Samsung Bioepis, No. 19-11755 (D.N.J.) |
ETICOVO (etanercept-ykro) [approved] |
ENBREL [litigation #2] |
Apr. 29, 2019 | Pending (administratively stayed) | |
| 26 |
Amgen v. Tanvex, No. 19-1374 (D.N.J.) |
TX-01 (filgrastim biosimilar) [not approved] |
NEUPOGEN [litigation #5] |
July 23, 2019 | Settled | n/a |
Last updated: January 23, 2020
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