Samsung Bioepis, Biogen Get European Commission Approval For Opuviz, A Biosimilar To Aflibercept

(RTTNews) - Samsung Bioepis Co., Ltd. and Biogen Inc. (BIIB) Monday announced that the European Commission (EC) has approved Opuviz, a biosimilar to Regeneron Pharmaceuticals' Aflibercept.

Opuviz ia approved to treat neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema, and visual impairment due to myopic choroidal neovascularisation.

The approval was based on a Phase 3 study of Opuviz, which showed equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics profiles between Opuviz and reference Eylea.