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 and our quarterly BPCIA litigation roundup.
| # | Litigation | Accused Biosimilar [status] |
Reference Product [suit#] |
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® [#1] |
Oct. 24, 2014 | Summary judgment of non-infringement in favor of Sandoz | Pending in Fed. Cir. |
| 2 | Janssen v. Celltrion, No. 17-11008 (D. Mass.) |
Inflectra® (infliximab-dyyb) [approved; launched] |
Remicade® [#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® [#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® [#1] |
Sept. 18, 2015 | Jury found infringement and awarded Amgen $70M; Hospira’s post-trial motions denied | Pending in Fed. Cir. |
| 5 | Amgen v. Apotex, No. 15-62081 (S.D. Fla.) [consolidated with #3 above] |
Grastofil™ (filgrastim biosimilar) [not approved] |
Neupogen® [#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® [#1] |
Feb. 26, 2016 | Pending, post-trial | |
| 7 | Amgen v. Sandoz, No. 16-2581 (N.D. Cal.) [consolidated with #1 above] |
LA-EP2006 (pegfilgrastim biosimilar) [not approved] |
Neulasta® [#2] |
Mar. 4, 2016 | Summary judgment of non-infringement in favor of Sandoz | Pending in Fed. Cir. |
| 8 | AbbVie v. Amgen, No. 16-666 (D. Del.) |
Amjevita™ (adalimumab-atto) [approved] |
Humira® [#1] |
Aug. 4, 2016 | Settled | n/a |
| 9 | Amgen v. Coherus, No. 17-546 (D. Del.) |
Udenyca® (pegfilgrastim-cbqv) [approved; launched] |
Neulasta® [#3] |
May 10, 2017 | Motion to dismiss granted | Pending in Fed. Cir. |
| 10 | Janssen v. Samsung Bioepis, No. 17-3524 (D.N.J.) |
Renflexis® (infliximab-abda) [approved, launched] |
Remicade® [#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® [#2] |
Aug. 2, 2017 | Pending | |
| 12 | Amgen v. Mylan, No. 17-1235 (W.D. Pa.) |
Fulphila® (pegfilgrastim-jmdb) [approved; launched] |
Neulasta® [#4] |
Sept. 22, 2017 | Pending | |
| 13 | Genentech v. Amgen, Nos. 17-1407, -1471 (D. Del.) |
Mvasi™ (bevacizumab-awwb) [approved] |
Avastin® [#1] |
Oct. 6, 2017 | Pending | |
| 14 | Genentech v. Pfizer, No. 17-1672 (D. Del.) |
PF-05280014 (trastuzumab biosimilar) [not approved] |
Herceptin® [#1] |
Nov. 17, 2017 | Settled | n/a |
| 15 | Genentech v. Sandoz, No. 17-13507 (D.N.J.) |
Rixathon™ (rituximab biosimilar) [not approved] |
Rituxan® [#1] |
Dec. 21, 2017 | Settled | n/a |
| 16 | Genentech v. Celltrion, Nos. 18-095, -1025 (D. Del.) |
Herzuma™ (trastuzumab-pkrb) [approved] |
Herceptin® [#2] |
Jan. 12, 2018 | Settled | n/a |
| 17 | Genentech v. Celltrion, Nos. 18-574, -11553 (D.N.J.) |
Truxima™ (rituximab-abbs) [approved] |
Rituxan® [#2] |
Jan. 12, 2018 | Settled | n/a |
| 18 | Amgen v. Adello, No. 18-3347 (D.N.J.) |
TPI G-CSF (filgrastim biosimilar) [not approved] |
Neupogen® [#3] |
Mar. 8, 2018 | Pending | |
| 19 | Genentech v. Amgen, No. 18-924 (D. Del.) |
ABP 980 (trastuzumab biosimilar) [not approved] |
Herceptin® [#3] |
June 21, 2018 | Pending | |
| 20 |
Amgen v. Hospira, No. 18-1064 (D. Del.) |
Nivestym® (filgrastim-aafi) [approved] [launched] |
Neupogen® [#4] |
July 18, 2018 | Pending | |
| 21 |
Amgen v. 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® [#1]; Neupogen® [#2] |
Aug. 7, 2018 | Pending | |
| 22 |
AbbVie v. Sandoz, No. 18-12668 (D.N.J.) |
GP2017 (adalimumab biosimilar) [approved] |
Humira® [#3] |
Aug. 10, 2018 | Settled | n/a |
| 23 |
Genentech v. Samsung Bioepis, No. 18-1363 (D. Del.) |
SB3 (trastuzumab biosimilar) [not approved] |
Herceptin® [#4] |
Sept. 4, 2018 | Pending | |
Last updated: January 8, 2019
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