Biocon Biologics announced that the US Food and Drug Administration (FDA) has approved its denosumab biosimilars, Bosaya (denosumab-kyqq) 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso (denosumab-kyqq) 120 mg/1.7 mL (70 mg/mL) injection in a single-dose vial.  Bosaya is a biosimilar to Prolia, while Aukelso references Xgeva. Both products have also been granted a provisional interchangeability designation by the FDA.

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,” he added.

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 tumours, to treat adults and skeletally mature adolescents with giant cell tumour 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 their reference products.

According to IQVIA National Sales Perspectives Data, denosumab generated nearly USD 5 billion in US sales in 2024, with PROLIA contributing USD 3.3 billion and XGEVA USD 1.6 billion.  

Biocon Biologics has now commercialised 10 biosimilars across major markets, including the US, Europe, Australia, Canada, and Japan. Its pipeline of 20 biosimilar assets spans diabetology, oncology, immunology, ophthalmology, bone health, and other non-communicable diseases.