Posted by Michael Wonder on 04 Dec 2025
Pre-filled syringe presentation of Byooviz, Samsung Bioepis’ biosimilar to Lucentis (ranibizumab), gains European approval
2 December 2025 - Samsung Bioepis today announced that the EMA’s CHMP has adopted a positive opinion for Byooviz pre-filled syringe, a biosimilar referencing Lucentis (ranibizumab).
Byooviz was first approved by the European Commission in August 2021 as a single use vial for intravitreal use (0.5 mg/0.05 mL) 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 or central retinal vein) and visual impairment due to choroidal neovascularisation.
