The US FDA has approved the denosumab-dssb biosimilar to treat osteoporosis and increase bone mass. Denosumab is a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor.
Indication Postmenopausal women with osteoporosis at high risk for fracture Glucocorticoid-induced osteoporosis in men and women at high risk for fracture To increase bone mass o In men with osteoporosis at high risk for fracture o In men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer o In women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer Clinical evidence The safety and efficacy of the denosumab-dssb biosimilar were evaluated in clinical trials involving 7,808 women aged 60 to 91 years and 242 men aged 31 to 84 years. Denosumab significantly reduced the incidence of new vertebral fractures (2.3% vs.…
