FDA approves Byooviz, first ophthalmology biosimilar
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The FDA has approved Byooviz as a biosimilar to Lucentis for the treatment of some retinal diseases and conditions, including wet age-related macular degeneration, according to a press release from Samsung Bioepis and Biogen.
Byooviz (ranibizumab-nuna) is the first ophthalmology biosimilar to receive FDA approval. Other indications include the treatment of macular edema following retinal vein occlusion and myopic choroidal neovascularization.
“In the United States, approximately 11 million people are affected with AMD, and the prevalence of advanced AMD is growing due to the aging population. The approval of the first ranibizumab biosimilar in the U.S. is a monumental milestone for people living with retinal vascular disorders in the U.S.,” Kyung-Ah Kim, senior vice president and development division leader at Samsung Bioepis, said in the release.
The approval was based in part on a randomized, double-masked, parallel-group, multicenter phase 3 study investigating safety, efficacy, pharmacokinetics and immunogenicity of Byooviz vs. Lucentis (ranibizumab, Genentech) in wet AMD. The mean change from baseline in best corrected visual acuity at 52 weeks was 9.79 letters in patients treated with Byooviz compared with 10.41 letters in patients treated with ranibizumab, the release said. Safety data, including incidence of treatment-emergent adverse events, were comparable through 52 weeks.
Samsung Bioepis and Biogen can market Byooviz in the U.S. starting in June 2022, based on a global license agreement with Genentech.
Byooviz was approved in the European Union and the United Kingdom in August.
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