On February 16, the FDA approved Samsung Bioepis’ biologics license application for SB16, its denosumab biosimilar candidate. Dubbed Ospomyv for the treatment of postmenopausal women with osteoporosis (reference product Prolia), and Xbryk (denosumab-dssb) for the treatment of bone complications of oncology disorders (reference product Xgeva), this is the second denosumab biosimilar approval in the US. … Continue reading Samsung Bioepis Gets FDA Approval for Its Denosumab Biosimilar