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Health Canada approves Byooviz™ (biosimilar ranibizumab)

Mar 10, 2022

Samsung Bioepis and Biogen announced that Health Canada approved Byooviz™ (biosimilar ranibizumab) on 8 March for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and choroidal neovascularization (CNV) secondary to ocular conditions other than AMD or PM.  This is the first Health Canada approval of a biosimilar ranibizumab to date, and whilst is it Samsung’s 6th Canadian biosimilar, it is Biogen’s first.  Byooviz™ was approved in the US in September 2021, and in the EU and the UK in August 21.