Organon & Co. and Samsung Bioepis revealed that HADLIMA (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab), is now accessible to patients in the United States. This development ensures a seamless continuity of care as HADLIMA is available in both citrate-free high concentration (100 mg/mL) and citrate-containing low concentration (50 mg/mL), similar to Humira. HADLIMA, a tumor […]
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, 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 […]