On March 3, Celltrion announced that the FDA has approved the company’s denosumab biosimilars Stoboclo (reference product, Prolia) and Osenvelt (reference product Xgeva). The nonproprietary designation for both molecules is denosumab-bmwo. The approval covers all indications of the reference products, including osteoporosis with high risk of fracture in men and postmenopausal women, glucocorticoid-induced osteoporosis, increasing … Continue reading FDA Approves Celltrion’s Denosumab Biosimilars, to Launch in June