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…
On November 27, 2025, Celltrion announced that Health Canada approved EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron’s EYLEA® (aflibercept), in both vial and pre-filled syringe form, to treat all indications approved for EYLEA®. EYDENZELT® is Celltrion’s first biologic product approved in Canada in the ophthalmology space. According to media reports, Celltrion…
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…
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 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 Amgen’s aflibercept biosimilar, PAVBLU®. As we have previously reported, in…
On October 9, 2025, the FDA approved Celltrion’s aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron’s EYLEA® (aflibercept). This approval makes Celltrion the sixth company to receive FDA approval for an aflibercept biosimilar, joining Biocon, Samsung Bioepis, Formycon, Sandoz, and Amgen. Aflibercept is a recombinant fusion protein that binds to vascular endothelial…
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”),…
In the past few weeks, several biosimilar products have been granted marketing authorization in Europe and Japan, and additional products have been recommended for approval in Europe. The European Commission Approves Henlius and Organon’s Denosumab Biosimilars: On September 19, 2025, Shanghai Henlius Biotech and Organon announced that the European Commission…
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 September 17, 2025, Alvotech USA Inc. and Alvotech hf. (“Alvotech”) filed a Petition for Post Grant Review of U.S. Patent No. 12,168,036 (“the ‘036 patent”), assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). The ‘036 patent, entitled “Methods for treating angiogenic eye disorders with high doses of VEGF receptor fusion proteins,”…