Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Formycon asserting infringement of 39 US aflibercept patents. The heavily redacted Complaint states that on 29 August 2023 Formycon announced its aBLA for FYB203 was accepted for review by the FDA, and that this constitutes patent infringement. The Complaint also states on information and belief that on 30 August 2020 Formycon imported or directed the importation at least one shipment of FYB203 into the US.
This is Regeneron’s fourth aflibercept complaint filed in the US District Court for the Northern District of West Virginia. 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.