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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. […]

Samsung Bioepis, C-Bridge Capital collaborate to develop and commercialize biosimilars in China

Samsung Bioepis, a South Korean biopharma company, has signed a licensing agreement with private equity firm C-Bridge Capital to develop and commercialize next-generation biosimilars in China. The agreement covers Samsung Bioepis’ various biosimilar candidates like SB11 and SB12, which reference LUCENTIS (ranibizumab) and SOLIRIS (eculizumab), respectively, and also SB3, a biosimilar candidate referencing HERCEPTIN 3 […]

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