On 2 December 2024, Formycon filed a petition for inter partes review of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®. The petition closely followed a petition filed by Samsung Bioepis in relation to the same patent on 20 November 2024. Both petitions challenge the 865 patent for obviousness. Formycon has requested joinder of its petition with that of Samsung Bioepis.
Formycon/Klinge’s aflibercept biosimilar, Ahzantive®/FYB203, was approved in the US in June 2024. Samsung Bioepis’ Opuviz™/SB15 received US approval in May 2024. Other aflibercept biosimilars approved in the US are Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024) and Biocon’s Yesafili™ (May 2024). Amgen’s Pavblu® was launched in the US in October 2024 following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen earlier in October 2024.
This patent is hotly contested in the US. The US District Court for the Northern District of West Virginia recently granted 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 the same patent (Regeneron’s US patent 11,084,865). 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.