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 March 19, 2026, Formycon and its license partner Klinge Biopharma announced a settlement and license agreement with Regeneron and Bayer resolving all patent disputes relating to the EU-approved AHZANTIVE and BAIAMA aflibercept biosimilars referencing EYLEA. Nicola Mikulcik, Chief Business Officer of Formycon AG stated of the announcement, “The agreement…
On December 13, 2025, Biocon Biologics Ltd. (“Biocon”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) entered into a license and settlement agreement to dismiss all pending claims in the parties’ disputes over Biocon’s aflibercept biosimilar, YESAFILI® (aflibercept-jbvf) in Europe and the rest of the world, following an earlier settlement covering the United…
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”),…
On July 20, 2021, after nearly four years of litigation, Johnson & Johnson (J&J) and Pfizer have agreed to dismiss all claims asserted in the antitrust suit brought by Pfizer in the Eastern District of Pennsylvania regarding Remicade (infliximab). Remicade is an immunosuppressant that is used to treat Crohn’s disease,…
Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). Amgen’s ABP 959 is a biosimilar to SOLIRIS undergoing clinical trials with a phase 3 clinical trial initiated earlier…
This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan a non-exclusive license on specified dates to AbbVie’s intellectual property relating to HUMIRA in the United States and in various…