Biocon Biologics Gains USFDA Approval for Denosumab Biosimilars

Biocon Biologics, a subsidiary of Biocon, announced on Wednesday that it has received approval from the United States Food and Drug Administration (USFDA) for Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq). These are biosimilars of Amgen’s widely used osteoporosis and oncology drugs, Prolia and Xgeva.

Details of the Approvals

Bosaya is a 60 mg/mL prefilled syringe intended for subcutaneous use. It has been cleared for treating postmenopausal women and men with osteoporosis at high risk of fracture, glucocorticoid-induced osteoporosis, and bone loss linked to cancer therapies. Aukelso, supplied as a 120 mg/1.7 mL single-dose vial, has been approved for preventing skeletal-related events in patients with multiple myeloma or bone metastases. It is also indicated for giant cell tumour of bone and hypercalcaemia of malignancy unresponsive to bisphosphonate therapy.

Interchangeability Designation

The USFDA has also granted provisional interchangeability status for both Bosaya and Aukelso. This means pharmacies can substitute the biosimilars for the reference drugs, subject to state-level regulations. Clinical studies have shown that the products match Prolia and Xgeva in terms of safety, efficacy, and quality.

Market Opportunity

According to IQVIA data, denosumab generated close to $5 billion in sales in the United States for the year ended December 2024. Prolia accounted for $3.3 billion of this, while Xgeva contributed $1.6 billion. The approvals give Biocon Biologics access to a significant market, positioning the company to provide more affordable alternatives in the bone health and oncology segments.

Company Statement

Shreehas Tambe, CEO and Managing Director of Biocon Biologics, said in an interview with CNBC TV18 that the approvals are a milestone in expanding the company’s portfolio. He added that the launch “supports sustainable healthcare systems by offering more affordable treatment options” while broadening Biocon’s presence in oncology and bone-related therapies.

Read More: Shukra Pharmaceuticals Signs Strategic Distribution Agreement With Wockhardt

Conclusion

The USFDA approvals for Bosaya and Aukelso mark a significant step for Biocon Biologics in the competitive biosimilars space. By targeting high-value therapies in osteoporosis and oncology, the company aims to enhance patient access to treatment while contributing to healthcare affordability in the United States.

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