At its September meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s and Samsung Bioepis/Biogen’s biosimilars to Regeneron’s Eylea® (aflibercept). Both Sandoz’s Afqlir™ and Samsung Bioepis/Biogen’s Opuviz™, in 40 mg/ml solution for injection, are indicated for nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).
Opuviz™ (SB15) is the subject of a commercialisation agreement between Samsung Bioepis and Biogen for US, Canada, Europe, Japan and Australia, entered in November 2019. The agreement also covers a second ophthalmology biosimilar, Byooviz (SB11, ranibizumab).
Celltrion’s Yesafili® is currently the only aflibercept biosimilar approved in the EU (September 2023, with UK approval following in November 2023). Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023 and Alvotech/Advanz Pharma’s MAA for AVT06 (aflibercept) was accepted by 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.
At its September meeting, CHMP additionally adopted positive opinions for three innovator biologics and extended indications for five as reported here.