Biocon Biologics Wins FDA Nod for Denosumab Biosimilars

Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., reported today that it received approval for denosumab biosimilars, Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), from the U.S. Food and Drug Administration (FDA).

Bosaya is a biosimilar to Prolia in 60 mg/mL injection in a prefilled syringe. Aukelso is a biosimilar to Xgeva in 120 mg/1.7 mL injection in a single-dose vial. Both products have received provisional interchangeability designation from the FDA.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, hailed the milestone as a statement of the company's scientific diligence and regulatory capability.

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Bosaya will provide patients with osteoporosis an affordable treatment option, and Aukelso will assist the company's oncology portfolio by providing support for multiple myeloma, bone metastasis, giant cell tumor of bone, and hypercalcemia of malignancy patients.

Bosaya has been approved for multiple indications, such as osteoporosis in postmenopausal women, glucocorticoid-induced osteoporosis, and bone loss associated with cancer treatment. Its Risk Evaluation and Mitigation Strategy (REMS), used as a warning to healthcare providers for patients with advanced chronic kidney disease, is similar to that of Prolia.

Denosumab sales in the U.S. were about $5 billion in 2024 (IQVIA), with Prolia sales at $3.3 billion and Xgeva at $1.6 billion, giving Biocon Biologics a new opportunity to enter a profitable market and fulfill its goal to provide better access to high-quality biosimilars for patients.