As we previously reported, portions of CareFirst’s antitrust claims concerning STELARA® (ustekinumab) survived summary judgment in December 2025. On January 14, 2026, the U.S. District Court for the Eastern District of Virginia reconsidered that decision and granted summary judgment to Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) on…
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 for the District of Delaware against Amgen Inc. (“Amgen”), alleging that Amgen’s proposed nivolumab biosimilar, ABP 206, will infringe seven…
On September 1, 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 against Alvotech HF (“Alvotech”), alleging that Alvotech’s proposed vedolizumab biosimilar, AVT16, will infringe six patents related to Takeda’s ENTYVIO® (vedolizumab)….
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 Alvotech hf. and Alvotech USA Inc. (collectively, “Alvotech”) for patent infringement related to Alvotech’s proposed golimumab biosimilars (AVT05 SC and…
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 their denosumab biosimilars, BILPREVDA® (denosumab‑nxxp) and BILDYOS® (denosumab‑nxxp), following a settlement between the parties. Under the consent judgment, Henlius and…
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the…
On February 11, 2026, Samsung Bioepis, Co., Ltd (“Samsung”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Joint Stipulation and Proposed Order seeking to dismiss all claims and counterclaims without prejudice and to vacate the preliminary injunction previously entered against Samsung. According to Regeneron, the parties entered into a settlement agreement…
This past year contained a number of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top three legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Start to Resolve As in 2023 and 2024, Regeneron’s multi-district…
As we have previously reported, a group of health insurers and health insurance administrators (collectively, “CareFirst”) filed a class action complaint in 2023 against Johnson & Johnson and Janssen Biotech, Inc. (collectively, J&J), alleging multiple violations of federal and state antitrust laws arising from J&J’s STELARA® (utsekinumab) product, as well…
On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem Laboratories Ltd., Ascend Laboratories, LLC, and Enzene Biosciences Ltd. (“Alkem”) related to Alkem’s submission to the FDA of a Biologic…