On 18 November 2024, Samsung Bioepis and Biogen announced that the European Commission has approved Opuviz™/SB15, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept). A positive CHMP opinion was adopted for Opuviz™ in September 2024.
Opuviz™ is approved for the treatment of nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO); diabetic macular oedema (DME), and myopic choroidal neovascularisation (CNV).
Samsung Bioepis and Biogen entered into a commercialisation agreement for Opuviz™ (SB15) in November 2019 for US, Canada, Europe, Japan and Australia. The agreement also covers a second ophthalmology biosimilar, Byooviz™ (SB11, ranibizumab).
Opuviz™ is the third aflibercept biosimilar to be approved in the EU, closely following last week’s approval of Sandoz’s Afqlir®. Biocon’s Yesafili® was approved in September 2023 (with UK approval following in November 2023). Alvotech/Advanz Pharma’s MAA for AVT06 (aflibercept) was accepted by the EMA in August 2024. In July 2024, Altos Biologics announced that it submitted an MAA to the EMA for its aflibercept biosimilar ALT-L9, with marketing approval expected in 2025. Formycon/Klinge announced on 15 November 2024 that their aflibercept biosimilar FYB203/Baiama®/Ahzantive® received a positive opinion from the CHMP.