FDA Accepts Application From Samsung Bioepis and Biogen For Lucentis® (ranibizumab) Biosimilar

Samsung Bioepis and Biogen issued a press release on November 18 announcing that the U.S. Food and Drug Administration has accepted for review their Biologics License Application for SB11, a proposed biosimilar of Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy used to treat retinal vascular disorders, which are a leading cause of blindness.  The press release follows on the heels of the companies’ announcement in October 2020 that the European Medicines Agency (EMA) had accepted for review their Marketing Authorization Application for SB11.  These applications appear to be fruit of the commercialization agreement Samsung Bioepis and Biogen inked in November 2019 for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the United States, Canada, Europe, Japan and Australia.