Test 2 – BPCIA Litigations

Pending U.S. District Court BPCIA Litigations

Bevacivumab+

Genentech v. Samsung Bioepis, No. 20-859 (D. Del.)

  • Accused Biosimilar [status]: SB8 (bevacizumab biosimilar) [not approved]
  • Reference Product: AVASTIN [litigation #3]
  • Complaint Filed: June 28, 2020
  • Status/Outcome

 

Resolved U.S. District Court BPCIA Litigations

Filgrastim+

Amgen v. Sandoz, No. 14-474 (N.D. Cal.), [consolidated with #7 below]

Amgen v. Apotex, No. 15-62081 (S.D. Fla.) [consolidated with #3 above]

  • Accused Biosimilar [status]: Grastofil (filgrastim biosimilar) [not approved]
  • Reference Product: NEUPOGEN [litigation #2]
  • Complaint Filed: Oct. 2, 2015
  • Status/Outcome

Amgen v. Kashiv (formerly Adello), No. 18-3347 (D.N.J.)

Amgen v. Tanvex, No. 19-1374 (S.D. Cal.)

Amgen v. Hospira, Nos. 18-1064, 20-561 (D. Del.)

Infliximab+

Janssen v. Celltrion, No. 17-11008 (D. Mass.)

Janssen v. Samsung Bioepis, No. 17-3524 (D.N.J.)

Pegfilgrastim+

Amgen v. Apotex, No. 15-61631 (S.D. Fla.) [consolidated with #5 below]

  • Accused Biosimilar [status]: Lapelga (pegfilgrastim biosimilar) [not approved]
  • Reference Product: NEULASTA [litigation #1]
  • Complaint Filed: Aug. 6, 2015
  • Status/Outcome

Amgen v. Sandoz, No. 16-2581 (N.D. Cal.) [consolidated with #1 above]

Amgen v. Coherus, No. 17-546 (D. Del.)

Amgen v. Mylan, No. 17-1235 (W.D. Pa.)

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]
  • Complaint Filed: Aug. 7, 2018
  • Status/Outcome

Amgen v. Hospira, No. 20-201 (D. Del.)

Epoetin alfa+

Amgen v. Hospira, No. 15-839 (D. Del.)

Etanercept+

Immunex v. Sandoz, No. 16-01118 (D.N.J.)

Immunex v. Samsung Bioepis, No. 19-11755 (D.N.J.)

Adalimumab+

AbbVie v. Amgen, No. 16-666 (D. Del.)

AbbVie v. Boehringer Ingelheim, No. 17-1065 (D. Del.)

AbbVie v. Sandoz, No. 18-12668 (D.N.J.)

AbbVie v. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.)

  • AVT02 (adalimumab biosimilar) [not approved]
  • HUMIRA [litigation #4]
  • Complaint Filed: April 27, 2021, May 28, 2021
  • Status/Outcome

Bevacizumab+

Genentech v. Amgen, Nos. 17-1407, -1471, 19-602 (D. Del.)

Genentech v. Pfizer, No. 19-638 (D. Del.)

Genentech v. Centus, No. 20-361 (E.D. Tex.)

Trastuzumab+

Genentech v. Pfizer, No. 17-1672 (D. Del.)

Genentech v. Pfizer, No. 17-1672 (D. Del.)

Genentech v. Celltrion, Nos. 18-095, -1025 (D. Del.)

Genentech v. Amgen, No. 18-924 (D. Del.)

Genentech v. Samsung Bioepis, No. 18-1363 (D. Del.)

Rituximab+

Genentech v. Sandoz, No. 17-13507 (D.N.J.)

Genentech v. Celltrion, Nos. 18-574, -11553 (D.N.J.)

Last updated: April 10, 2022