FX.co ★ Samsung Bioepis, Biogen Get European Commission Approval For Opuviz, A Biosimilar To Aflibercept

Samsung Bioepis Co., Ltd. and Biogen Inc. (BIIB) officially announced on Monday that the European Commission (EC) has granted approval for Opuviz, a biosimilar to Aflibercept from Regeneron Pharmaceuticals.

Opuviz is now authorized for the treatment of various conditions, including neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion, visual impairment resulting from diabetic macular edema, and visual impairment due to myopic choroidal neovascularization.

This approval follows a Phase 3 clinical study that demonstrated Opuviz's equivalent efficacy and provided a comparative analysis of safety, immunogenicity, and pharmacokinetics profiles when measured against the reference product, Eylea.