On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval increases the maximum dosing interval from 16 weeks to 20…
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 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…
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 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 (“AFRS”), with a target action date of February 28, 2026….
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…
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…