Posted by Michael Wonder on 27 Jun 2021
Samsung Bioepis and Biogen receive positive CHMP opinion for ranibizumab biosimilar, Byooviz
25 June 2021 - Samsung Bioepis and Biogen today announced that the EMA's CHMP has adopted a positive opinion for Byooviz, a biosimilar candidate referencing Lucentis (ranibizumab), also known as SB11.
Byooviz has been recommended for approval for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch retinal vein occlusion or central retinal vein occlusion) and visual impairment due to choroidal neovascularisation in the European Union.
