On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept biosimilar pending appeal. That appeal concerns a September 2024 decision of the US District Court for the Northern District of West Virginia denying Regeneron’s motion for a preliminary injunction against Amgen.
However, the Appeals Court has agreed to expedite the appeal proceeding, with the hearing set for January 2025.
Following the decision of the Appeals Court, media reports reveal that Amgen intends to launch its US aflibercept biosimilar, Pavblu™, “as quickly as possible”. Pavblu™, biosimilar to Regeneron’s Eylea® was approved by the FDA in August 2024 for nAMD, macular oedema following RVO, diabetic macular oedema and diabetic retinopathy.
The proceedings brought by Regeneron against Amgen are part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of 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 US District 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.