Biocon’s arm gets USFDA’s nod for Bosaya, Aukelso

18 Sep 2025 Evaluate

Biocon’s subsidiary -- Biocon Biologics (BBL) has received approval from U.S. Food and Drug Administration (USFDA) for Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS) and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilars of Prolia and Xgeva respectively. In addition, the USFDA granted provisional interchangeability designation for both BOSAYA and AUKELSO.

BOSAYA is approved for the treatment of 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 for 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 is approved for the prevention of 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 is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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