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"), Samsung Bioepis Co., Ltd. ("Samsung"), and Sandoz, Inc. ("Sandoz"). As we have previously reported, the Federal Circuit affirmed preliminary injunctions against Celltrion, Formycon, and Samsung, and denied the entry of a preliminary injunction against Amgen. As we also reported, Mylan and Biocon settled their BPCIA dispute with Regeneron earlier this year and Sandoz followed suit earlier this month.
Celltrion's Anticipated Motion to Dissolve Preliminary Injunction
On September 15, 2025, Celltrion and Regeneron filed a Stipulation and Briefing Schedule concerning Celltrion's forthcoming motion to dissolve the preliminary injunction. The stipulation does not indicate the basis for seeking to dissolve the preliminary injunction and Regeneron confirmed that it will oppose such a motion. Under the agreed briefing schedule, Celltrion's opening brief is due October 31, 2025, Regeneron's opposition brief is due November 21, 2025, and Celltrion's reply brief is due December 12, 2025.
Formycon and Regeneron Settle Aflibercept BPCIA Case
On September 29, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing without prejudice all claims and defenses asserted by Regeneron against Formycon relating to Formycon's 2 mg aflibercept product, as well as all counterclaims and defenses asserted by Formycon against Regeneron. The Court also vacated the preliminary injunction previously entered against Formycon, in view of the parties' settlement agreement resolving the BPCIA litigation regarding Formycon's aflibercept biosimilar, AHZANTIVE (aflibercept-mrbb).
Stay tuned to Big Molecule Watch for further updates on the aflibercept BPCIA multi-district litigation.
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