Regeneron filed a Compliant in the US District Court for the Central District of California against Amgen asserting infringement of 32 aflibercept patents. The Complaint states that on 31 October 2023, Amgen announced that the FDA accepted its abbreviated Biologics Drug Application (aBLA) for ABP938, Amgen’s biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron is seeking a preliminary and permanent injunction against Amgen, a finding of willful infringement, damages (including enhanced damages for wilful infringement) and costs.
Regeneron filed its fourth aflibercept complaint in the US District Court for the Northern District of West Virginia against Formycon on 29 November 2023. Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion (on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.