Biocon Biologics gets US FDA nod for two drugs to treat osteoporosis, bone loss

Biocon Biologics Ltd, a subsidiary of Biocon Ltd, on Wednesday said it has received approval from the US Food and Drug Administration (FDA) for Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), biosimilars of Amgen’s Prolia and Xgeva, respectively.

Bosaya, a 60 mg/mL prefilled syringe for subcutaneous use, is approved for treating postmenopausal women and men with osteoporosis at high risk of fracture, glucocorticoid-induced osteoporosis, and bone loss due to cancer therapies. Aukelso, a 120 mg/1.7 mL single-dose vial, is approved for preventing skeletal-related events in patients with multiple myeloma or bone metastases, and for treating giant cell tumor of bone and hypercalcemia of malignancy refractory to bisphosphonate therapy.

The US FDA also granted provisional interchangeability designation for both products, allowing pharmacy-level substitution subject to state laws. Clinical data demonstrated comparable safety, efficacy and quality to reference products.

According to IQVIA, denosumab had nearly $5 billion in US sales for the year ended December 2024, with Prolia generating $3.3 billion and Xgeva $1.6 billion.

Biocon Biologics CEO & MD Shreehas Tambe said the approvals expand the company’s oncology and bone health portfolio and “support sustainable healthcare systems by offering more affordable treatment options.”

Shares of the company ended 1.6% lower at a price of ₹354.40 on the BSE. Last week's losses have dragged the stock 4% lower for the year-to-date.