Statute
BPCIA
102 published works
Big Molecule Watch
Genentech and Biocon Settle Pertuzumab Biosimilar BPCIA Litigation
On October 14, 2026, the U.S. District Court for the District of New Jersey entered an order dismissing without prejudice all claims in Genentech Inc. and Hoffmann-La Roche Inc.’s BPCIA litigation…
Big Molecule Watch
Janssen Granted Preliminary Injunction Against Golimumab Biosimilar
On September 30, 2026, the U.S. District Court for the District of Delaware issued an order granting Janssen Biotech, Inc. and Janssen Sciences Ireland UC’s (collectively, “Janssen”) motion for a…
Big Molecule Watch
USPTO Institutes Four IPRs Challenging Janssen’s Golimumab Method-of-Treatment Patents
By Grace Truong
On September 9, 2026, the U.S. Patent and Trademark Office issued a Notice of Decisions on Institution granting institution in four inter partes review proceedings challenging Janssen Biotech, Inc.’s golimumab…
Big Molecule Watch
BMS and Ono File BPCIA Suit Against Amgen for Nivolumab Biosimilar
By Alice Yoon
On September 8, 2026, Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., (collectively, “BMS”) and Ono Pharmaceutical Co., Ltd. (“Ono”) filed a BPCIA complaint in the U.S. District Court…
Big Molecule Watch
Takeda Files BPCIA Suit Against Polpharma Biologics For Vedolizumab Biosimilar
On August 26, 2026, Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG (collectively, “Takeda”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey…
Big Molecule Watch
Genentech Files BPCIA Patent Infringement Suit Against Biocon Over Proposed PERJETA Biosimilar
By Sarah Adam
On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”)…
Big Molecule Watch
Janssen Files BPCIA Complaint Against Alvotech Related to Golimumab Biosimilar
By Gabriella Montes|Wendy Leben
On June 19, 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA Complaint in the U.S. District Court for the Eastern District of Virginia against…
Big Molecule Watch
Amgen and Shanghai Henlius/Organon Settle Denosumab BPCIA Litigation
By Riley Wyberg
On March 31, 2026, the District Court for the District of New Jersey entered a Consent Order and Judgment in the BPCIA litigation Amgen brought against Henlius and Organon concerning…
Big Molecule Watch
Update: Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
By Natasha Daughtrey|Christopher Cassella
As we reported last week, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of…
Big Molecule Watch
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
By Christopher Cassella|Kevin DeJong
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma,…