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Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ™ [Yahoo! Finance]
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EC approval based on robust totality of evidence confirming biosimilarity to reference aflibercept in terms of quality, efficacy, and safety INCHEON, South Korea and CAMBRIDGE, Mass., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has approved OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), developed and registered by Samsung Bioepis. OPUVIZ, also known as SB15, is approved in adult patients for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). “Retinal disorders are affecting millions of people's lives in Europe, yet many patients face barriers to treatment due to high costs,
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