On 10 July 2024, the United States District Court for the Northern District of West Virginia made orders for a preliminary injunction restraining Celltrion from launching its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.
The orders follow a decision of the Court on 28 June 2024, which found that Regeneron had satisfied the criteria for a preliminary injunction, including demonstrating that it was likely to succeed in proving at trial that CT-P42 infringes claims of Regeneron’s US patent 11,084,865 (ophthalmic formulations of a VEGF antagonist).
Celltrion filed an appeal from the preliminary injunction order on 12 July 2024. Celltrion’s NDA for CT-P42 was filed with the FDA in June 2023.
In June 2024, the same Court also granted preliminary injunctions regarding US aflibercept biosimilars against Samsung Bioepis (14 June 2024; OpuvizTM/SB15 (aflibercept) approved May 2024) and Formycon (21 June 2024; Ahzantive®/FYB203 (aflibercept) approved June 2024). A permanent injunction was granted against Biocon (11 June 2024; YesafiliTM approved May 2024). Appeals are pending in relation to each of these injunctions.