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The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.
FDA announced on Sept. 17, 2021, that it has approved the first biosimilar to Lucentis (ranibizumab injection). Byooviz (ranibizumab-nuna), a monthly intravitreal injection, has been approved to treat eye diseases such as neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The agency based the approval on evidence that included structural and functional characterization, comparative clinical efficacy, and safety evaluations.
“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” said Sarah Yim, M.D., director of FDA’s Office of Therapeutic Biologics and Biosimilars, in a press release. “Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”