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
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Register Today: Webinar Series: An Overview of the Biosimilars Market in China, and Comparison with the US Market
Join Kevin DeJong, Huiya Wu, and David Chen in our next webinar, “An Overview of the Biosimilars Market in China, and Comparison with the US Market” on December 17th at 12:30 PM EST.
Since China’s NMPA approved the first biosimilar
European Commission Approves Alvotech’s and Teva’s Denosumab Biosimilars
On November 24, 2025, Alvotech announced that the European Commission (EC) has approved AVT03 as a biosimilar to Amgen’s PROLIA® and XGEVA® (denosumab) in the European Economic Area. AVT03 is approved in two presentations: as a biosimilar to PROLIA® 60
Formycon Announces New Dupilumab Biosimilar Candidate
On November 17, 2025 Formycon AG (“Formycon”) announced development of a dupilumab biosimilar, FYB208, referencing Regeneron and Sanofi’s DUPIXENT. Dupilumab is a monoclonal antibody therapy designed to treat immunological disease by blocking interleukin 4 and interleukin 13 receptor signaling-induced type
Sandoz Launches Natalizumab Biosimilar
On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis. TYRUKO® was approved by FDA in August 2023 to treat all indications
Sandoz and EirGenix Enter Licensing Agreement to Commercialize Proposed Pertuzumab Biosimilar
On November 12, 2025, Sandoz announced a licensing agreement with EirGenix to commercialize EG1206A (pertuzumab), a proposed biosimilar of Genentech’s PERJETA® (pertuzumab). Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to the product, excluding certain countries
Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar
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”)
FDA Approves Accord BioPharma’s Denosumab Biosimilars
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA.
Both OSVYRTI® and JUBEREQ® are
FDA Accepts Sanofi and Regeneron’s Dupixent sBLA for Priority Review
On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adults and children aged 6 years and older with allergic fungal rhinosinusitis
Regeneron Moves to Strike and Dismiss Amgen’s Counterclaims in Aflibercept Litigation
On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court for the Northern District of West Virginia.
The dispute centers on