Biocon Biologics, a subsidiary of Biocon Ltd., has won approval from the U.S. Food and Drug Administration (USFDA) for two denosumab biosimilars—Bosaya (denosumab-kyqq) 60 mg/mL prefilled syringe and Aukelso (denosumab-kyqq) 120 mg/1.7 mL single-dose vial—which will serve as biosimilar equivalents to Amgen’s Prolia and Xgeva. In a further boost, both products have been granted provisional interchangeability status by the USFDA.
Bosaya is approved for treating osteoporosis in postmenopausal women and men at high risk for fractures, glucocorticoid-induced osteoporosis, and for patients who are undergoing cancer therapies that increase bone loss—such as men receiving androgen deprivation therapy for prostate cancer and women on adjuvant aromatase inhibitors for breast cancer. Aukelso is cleared for oncology-associated bone complications: prevention of skeletal-related events in patients with multiple myeloma or solid tumour metastases to bone; treatment of giant cell tumour of bone in adults and adolescents if surgery is not possible or would lead to severe harm; and treatment of hypercalcaemia of malignancy when bisphosphonates fail.
In terms of safety, efficacy and quality, clinical trial data indicates that both biosimilars match their reference biologics. Bosaya will follow the same Risk Evaluation and Mitigation Strategy (REMS) as Prolia, which includes warnings around severe hypocalcaemia particularly among patients with advanced chronic kidney disease including those on dialysis.
From a market perspective, this approval taps into a large space. In 2024, denosumab products (Prolia + Xgeva) together generated nearly US$5 billion in U.S. sales—Prolia contributing about $3.3 billion and Xgeva about $1.6 billion. Biocon now has a chance to compete in both the high-volume osteoporosis treatment market and the bone-metastasis/oncology-related segment.
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, described the approvals as a “significant milestone” in the company’s mission to broaden access to critical biologic therapies, affirm its regulatory and scientific strength, and deliver high quality biosimilars to help reduce costs and improve patient outcomes.
This development follows earlier success for Biocon Biologics, including the USFDA approval of Kirsty, an interchangeable biosimilar of NovoLog for diabetes treatment.
Overall, obtaining approval and interchangeability for Bosaya and Aukelso is set to enhance Biocon Biologics’ footprint in the U.S. market and strengthen its pipeline across treatment areas that address both chronic disease (osteoporosis) and cancer-related complications.