Health Canada approves first Lucentis biosimilar
Samsung Bioepis and the Canadian subsidiary of US biotech major Biogen (Nasdaq: BIIB) today announced that Health Canada has approved Byooviz – a biosimilar referencing Lucentis (ranibizumab), which is marketed Novartis (NOVN: VX) and Roche’s (ROG: SIX).
Byooviz is cleared 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, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous choriorentinopathy or idiopathic chorioretinaopathy.
Samsung Bioepis was a South Korean joint venture between Samsung Biologics KRX: 207940) and Biogen, but in January Samsung Biologics agreed to buy Biogen’s 49% stake in the company for $2.3 billion.
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