On 23 September 2024, the United States District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction against Amgen seeking to prevent it from launching Pavblu™, biosimilar to Regeneron’s Eylea® (aflibercept), in the US. The order is currently under seal.
On the same date, Regeneron filed an appeal from the preliminary injunction determination.
The proceeding against Amgen is part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Amgen (aBLA for ABP 938/Pavblu™ accepted by FDA in October 2023 and approved in August 2024), Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).
The Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the same Court to grant preliminary injunctions against Samsung Bioepis (14 June 2024), Formycon (21 June 2024) and Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of Regeneron’s US patent 11,084,865 (ophthalmic formulations of a VEGF antagonist).
Samsung Bioepis, Formycon and Celltrion lodged appeals from the preliminary injunction orders (on 14 June 2024, 25 June 2024, and 10 July 2024, respectively). Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. Those appeals are all pending.