Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis)
Shots:
- The CHMP has recommended Samsung Bioepis’ Byooviz (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26
- Byooviz is indicated 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 macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization (CNV)
- In Oct’25, Samsung Bioepis reported it will assume full commercial responsibility for Byooviz in the EU starting Jan’26
Ref: Samsung Bioepis | Image: Samsung Bioepis | Press Release
Related News:- Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com


