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FDA accepts BLA for Lucentis referencing ophthalmology biosimilar SB11

FDA accepts BLA for Lucentis referencing ophthalmology biosimilar SB11

Samsung Bioepis and Biogen said that the US Food and Drug Administration (FDA) has accepted for review the biologics license application for SB11, a proposed ophthalmology biosimilar referencing Genentech’s Lucentis (ranibizumab). Ranibizumab is an anti vascular endothelial growth factor (VEGF) therapy for retinal vascular disorders, which are a major cause of blindness in the US. […]