BPCIA Litigations

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
9 Amgen v. Coherus,
No. 17-546 (D. Del.)
Udenyca™(pegfilgrastim-cbqv)
[approved]
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
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 Pending
15 Genentech v. Sandoz,
No. 17-13507 (D.N.J.)
Rixathon™ (rituximab biosimilar)
[not approved]
Rituxan®
[#1]
Dec. 21, 2017 Pending
16 Genentech v. Celltrion,
Nos. 18-095, -1025 (D. Del.)
Herzuma™ (trastuzumab biosimilar)
[not approved]
Herceptin®
[#2]
Jan. 12, 2018 Pending
17 Genentech v. Celltrion,
Nos. 18-574, -11553 (D.N.J.)
Truxima™ (rituximab biosimilar)
[not approved]
Rituxan®
[#2]
Jan. 12, 2018 Settled
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
23
Genentech v. Samsung Bioepis,
No. 18-1363 (D. Del.)
SB3 (trastuzumab biosimilar)
[not approved]
Herceptin®
[#4]
Sept. 4, 2018 Pending

Last updated: November 14, 2018