Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced 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), 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 U.S. FDA granted provisional interchangeability designation for both Bosaya and Aukelso.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said, “The FDA’s approval of Bosaya and Aukelso is a significant milestone in our mission to expand access to critical biologic therapies. With Bosaya, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso, we are further expanding our oncology care portfolio. This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable healthcare systems and improve patient outcomes.”

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, glucocorticoidinduced 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. BOSAYA is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as PROLIA to likewise inform healthcare providers and patients of the risks of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with Bosaya.

According to IQVIA National Sales Perspectives Data, denosumab had nearly $5 billion in U.S. sales for the period ended December 2024, with PROLIA achieving $3.3 billion and XGEVA generating $1.6 billion.