On 12 August 2024, Sandoz announced that the FDA has approved Enzeevu™ (aflibercept-abzv) biosimilar to Regeneron’s Eylea® for nAMD.
Enzeevu™ is the fourth aflibercept biosimilar to be approved in the US, following Samsung Bioepis’ Opuviz™/SB15 (May 2024), Biocon’s Yesafili™ (May 2024) and Formycon/Klinge’s Ahzantive®/FYB203 (June 2024). Opuviz™, Yesafili™ and Ahzantive® are each approved for nAMD, macular oedema following retinal vein occlusion, diabetic retinopathy and diabetic macular oedema.
Regeneron has sued Samsung Bioepis (2 actions), Biocon, Formycon, Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Amgen (aBLA for ABP 938 accepted by FDA in October 2023), in US BPCIA litigation regarding aflibercept biosimilars. Preliminary injunctions were issued in relation to Formycon’s and Samsung Bioepis’ aflibercept biosimilars on 21 and 14 June 2024, respectively, while a permanent injunction was granted against Biocon on 11 June 2024. Both Samsung Bioepis and Formycon lodged appeals from the preliminary injunction orders (on 14 June 2024 and 25 June 2024, respectively). Biocon filed a Notice of Appeal on 21 June 2024.
Sandoz is not a party to the current BPCIA litigation. However, Sandoz’s media release states that the “launch timing” for Enzeevu™ “will be dependent on several factors, including the progress and outcome of pending or potential future related litigations or any potential settlements”.