- The U.S. FDA has approved Biogen (NASDAQ:BIIB) and Samsung Bioepis' Byooviz (ranibizumab-nuna).
- Byooviz is a biosimilar referencing Roche (OTCQX:RHHBY) company Genentech's Lucentis (ranibizumab), and is Samsung Bioepis’ fifth biosimilar approved in the U.S.
- The approval allows for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization ((mCNV)).
- The EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for Byooviz, in June.