Biocon Biologics Ltd., a fully integrated global biosimilars company and subsidiary of Biocon Ltd., announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous use in a single dose prefilled syringe (PFS), biosimilar of Amgen, Inc.'s (AMGN) Prolia.
The FDA also approved Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial, biosimilar of Amgen's Xgeva.
In addition, the U.S. FDA 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.
Clinical data showed that both biosimilars demonstrated comparable quality, safety, and efficacy to the reference product.
According to IQVIA National Sales Perspectives Data, denosumab had nearly $5 billion in U.S. sales for the period ending December 2024, with PROLIA achieving $3.3 billion and XGEVA generating $1.6 billion.
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