The US FDA has approved denosumab-qbde, a RANK ligand (RANKL) inhibitor biosimilar to denosumab, used in the treatment of osteoporosis. Denosumab-qbde is a human monoclonal antibody (IgG2) that targets and binds with high affinity to RANKL, inhibiting its interaction with the RANK receptor on osteoclasts and their precursors.
Denosumab-qbde is indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer Clinical evidence In clinical trials involving 473…
