SB 11 biosimilar filed with FDA for retinal vascular disorders.- Samsung Bioepis + Biogen

Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the FDA has accepted for review the Biologics License Application for SB 11 (ranibizumab biosimilar), a proposed biosimilar referencing Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are a leading cause of blindness in the United States. In October 2020 the Marketing Authorization Application (MAA) for SB 11 was accepted for review by the European Medicines Agency (EMA). If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe; Benpali, Imraldi and Flixabi. Samsung Bioepis announced in November 2019 that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, SB 11 (ranibizumab) and SB 15 (aflibercept), in the U.S., Canada, Europe, Japan and Australia.