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# FDA Approves 2 Biocon Denosumab Biosimilars
- URL: https://www.fdaweb.com/fda-approves-2-biocon-denosumab-biosimilars/
- Published: 2025-09-18T12:00:00.000Z
- Updated: 2026-09-14T15:22:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159893

FDA has approved Biocon Biologics’ Bosaya and Aukelso, biosimilars for Amgen’s Prolia (denosumab) and Xgeva (denosumab). The agency also granted provisional interchangeability for both biosimilars.

A Biocon [announcement](https://www.biocon.com/biocon-biologics-receives-u-s-food-and-drug-administration-approval-for-bosaya-and-aukelso-denosumab-biosimilars/?ref=fdaweb.com) says that Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single prefilled syringe, is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis in men and women at high risk of fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Aukelso (denosumab-kyqq) 120 mg/mL injection for subcutaneous use in a single-dose vial, is approved to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Biocon says denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL, it says, is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, according to Biocon, denosumab reduces bone breakdown, increasing bone mass and strength.