Biocon Wins Health Canada Nod for Denosumab Biosimilars Bosaya & Vevzuo

In a filing to exchange, the company stated that the approval, granted on April 3, 2026, covers Bosaya as a biosimilar to Prolia and Vevzuo as a biosimilar to Xgeva, two widely used denosumab products that play a key role in bone health by increasing bone mass and treating bone complications associated with cancer. Bosaya has been approved for treatment of postmenopausal women with osteoporosis at high risk for fracture, men with osteoporosis or nonmetastatic prostate cancer receiving androgen deprivation therapy, women with nonmetastatic breast cancer receiving adjuvant aromatase inhibitor therapy, and patients at high risk fracture due to sustained systemic glucocorticoid therapy, company noted.Vevzuo has been approved for reducing the risk of skeleton-related events in patients with multiple myeloma and bone metastases from breast, prostate, non-small cell lung cancer, and other solid tumours. It has also been approved for adults and skeletally mature adolescents with giant cell tumour of bone, as well as for hypercalcemia of malignancy refractory to intravenous bisphosphonate therapy.Both biosimilars were approved in their most common presentations, with Bosaya as a 60 mg/mL injection for subsutaneous use in a prefilled syringe, and Vevzuo as a 120 mg/1.7 mL injection in a single-dose vial.Shreehas Tambe, CEO & Managing Director, Biocon Ltd., said, "Health Canada's approval of Bosaya and Vevzuo marks another important milestone for Biocon as we continue to expand access to high-quality biosimilars in key global markets. This approval reflects our strong scientific and regulatory capabilities and reinforces our commitment to patients living with osteoporosis and cancer-related bone conditions."The approvals are based on a comprehensive package of analytical, nonclinical, and clinical data demonstrating that both biosimilars are highly similar to their reference products with no clinically meaningful differences in quality, safety, or efficacy, Biocon noted.

- ANI