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 December 11, 2025, Regeneron filed a Memorandum in Support of Its Motion to Bifurcate and Stay Amgen’s Antitrust Claims in the ongoing aflibercept patent litigation in the U.S. District Court for the Northern District of West Virginia. As we previously reported, Regeneron filed a second complaint against Amgen in…
On November 24, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. and Amgen Manufacturing Limited (“Amgen”), Hikma Pharmaceuticals USA Inc. (“Hikma”), and Gedeon Richter Plc., Gedeon Richter (Schweiz) AG, and Gedeon Richter USA,…
The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen Inc. (“Amgen”), Mylan Pharmaceuticals Inc. (“Mylan”), Biocon Biologics Inc. (“Biocon”), Celltrion, Inc. (“Celltrion”), Formycon AG (“Formycon”),…
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ‘099 patent issued on June 17, 2025, almost eight months after Amgen announced the launch of PAVBLU on…
On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co., Ltd. (together, “Henlius”) and Organon LLC and Organon & Co. (together, “Organon”) seeking approval…
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. (“Hikma”),…