FDA Approves Teva’s Degevma Biosimilar for Cancer-Related Bone Complications

Teva announced that the U.S. Food and Drug Administration approved Degevma (denosumab-adet), its biosimilar to Xgeva, for several cancer-related bone conditions. The approved uses include preventing skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors; treating giant cell tumor of bone in adults and skeletally mature adolescents when it cannot be removed or surgery would cause severe harm; and treating hypercalcemia of malignancy that has not responded to bisphosphonate therapy. Teva said comparative evidence found no clinically meaningful differences in safety, purity or potency from the reference drug. The Israel-based company expects a U.S. launch in the coming months; it has not announced that sales have begun there.