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INCHEON, Korea and CAMBRIDGE, Mass., June 25, 2021 (GLOBE NEWSWIRE) — Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis®1 (ranibizumab), also known as SB11. Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. BYOOVIZ has been recommended for approval for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular odemea secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV) in the European Union (EU).
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