Biocon Biologics Receives U.S. FDA Approval for Bosaya™ and Aukelso™, Denosumab Biosimilars

Biocon Biologics Ltd., a fully integrated global biosimilars company, has announced that the U.S. Food and Drug Administration (FDA) has approved Bosaya™ and Aukelso™, denosumab biosimilars of Prolia® and Xgeva® respectively. The FDA also granted provisional interchangeability designation for both BOSAYA and AUKELSO. Bosaya™ is approved for the treatment of osteoporosis and glucocorticoid-induced osteoporosis, while Aukelso™ is approved for the prevention of skeletal-related events in multiple myeloma and bone metastases from solid tumors, among other uses. The biosimilars demonstrated comparable quality, safety, and efficacy to the reference product.