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TGA approves Samsung Bioepis’ Byooviz® (biosimilar ranibizumab)

Aug 24, 2022

Samsung Bioepis’ Byooviz® (biosimilar ranibizumab) was approved in Australia 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 choroidal neovascularisation (CNV) or choroidal neovascularisation (CNV) secondary to pathologic myopia (PM), and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).  Byooviz was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019.

Samsung Bioepis obtained marketing approval for Byooviz in the US and EU in September 2021, Canada in March 2022, and in Korea in May 2022.  It was reported in September 2021 that Samsung Bioepis took a licence for ranibizumab from Genentech from June 2022.