Biosimilars company Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE: 532523) (NSE: BIOCON), announced on Wednesday that it has secured U.S. Food and Drug Administration (FDA) approval for Bosaya and Aukelso, biosimilars of Amgen's Prolia and Xgeva. The FDA also granted provisional interchangeability status for both products.

Bosaya (denosumab-kyqq) is approved for multiple osteoporosis indications, including postmenopausal women and men at high risk of fracture, as well as for patients with hormone-related bone loss. Aukelso (denosumab-kyqq) is cleared for oncology-related uses, including prevention of skeletal events in multiple myeloma and solid tumor bone metastases, treatment of giant cell tumor of bone, and hypercalcemia of malignancy.

Denosumab products generated nearly USD5bn in US sales in 2024, according to IQVIA, with Prolia contributing USD3.3bn and Xgeva USD1.6bn. Biocon Biologics said the approvals strengthen its oncology and bone health portfolio and support its mission to expand access to biologic therapies.

CEO and Managing Director Shreehas Tambe described the approvals as a milestone that underscores the company's scientific and regulatory capabilities while delivering affordable alternatives for patients and healthcare systems.

Both products carry safety warnings, including risks of severe hypocalcemia, particularly in patients with advanced chronic kidney disease, and potential for osteonecrosis of the jaw, atypical femoral fractures and serious infections.

Biocon Biologics has a portfolio of 10 commercialized biosimilars across more than 120 countries and a pipeline of 20 assets spanning oncology, immunology, diabetology and other chronic diseases.