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. […]

Samsung Bioepis partners with C-Bridge Capital to expand biosimilar portfolio in China

Samsung Bioepis partners with C-Bridge Capital to expand biosimilar portfolio in China

Samsung Bioepis, a South Korean leader in biopharmaceuticals, has struck a deal with private equity firm C-Bridge Capital to develop and commercialize next-generation biosimilars in China. This strategic licensing agreement will see C-Bridge set up a new biopharma venture, AffaMed Therapeutics, to collaborate with Samsung Bioepis on key areas including clinical development, regulatory registration, and […]