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FDA Approves Samsung Bioepis' Byooviz, A Proposed Biosimilar To Lucentis - Quick Facts

Samsung Bioepis Co., Ltd. and Biogen Inc. (BIIB) announced Monday that the U.S. Food and Drug Administration (FDA) has approved Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Ranibizumab is an anti-vascular endothelial growth factor (VEGF) therapy that prevents vision loss in patients with retinal vascular disorders which can cause irreversible blindness or visual impairments in adults in the U.S.

Byooviz is the first ophthalmology biosimilar approved in the U.S. Biosimilars are products that have been demonstrated to be similar in efficacy and safety to the originator's reference product, with the advantage that they offer cost savings and promote sustainable access to therapies.

The FDA approval of Byooviz was based on a totality of evidence including analytical, non-clinical data, and clinical data. Byooviz is Samsung Bioepis' fifth biosimilar approved in the U.S.

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