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SEPTEMBER 21, 2021

FDA Approves Byooviz Biosimilar for nAMD, Other Eye Conditions

By SPC News Staff

The FDA approved ranibizumab-nuna (Byooviz, Samsung Bioepis/Biogen) as the first biosimilar to ranibizumab injection (Lucentis, Genentech) to treat several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged 65 years and older.

Ranibizumab-nuna is also approved to treat macular edema following retinal vein occlusion and myopic choroidal neovascularization (mCNV), a