On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn preliminary injunctions preventing Samsung Bioepis and Formycon from launching their biosimilars to Regeneron’s Eylea® (aflibercept) in the US without a licence from Regeneron.
In both cases, the Appeals Court affirmed the earlier decisions of the US District Court for the Northern District of West Virginia (dated 14 June 2024 for Samsung Bioepis, and 21 June 2024 for Formycon), finding that Samsung Bioepis and Formycon each infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept. It is not known whether the decisions will be appealed to the US Supreme Court.
The BPCIA proceedings were initially commenced by Regeneron against Samsung Bioepis in November and December 2023, and against Formycon in November 2023. Samsung Bioepis’ aflibercept biosimilar Opuviz™/SB15 received US approval in May 2024, while Formycon’s Ahzantive®/FYB203 was approved June 2024.
The US District Court for the Northern District of West Virginia has also granted a preliminary injunction against Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the same patent (US ‘865). Celltrion lodged an appeal from its preliminary injunction order on 10 July 2024. Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. Those appeals are pending.
In October 2024, the Court of Appeals denied Regeneron’s application for an injunction against Amgen. Amgen launched its aflibercept biosimilar, Pavblu®, in the US later the same month.
Samsung Bioepis, Formycon and Celltrion are challenging Regeneron’s ‘865 patent before the USPTO, each having filed a petition for inter partes review (in November 2024, December 2024 and January 2025, respectively).