Biopharma
Biocon receives Health Canada approval for Bosaya and Vevzuo biosimilars to Prolia and Xgeva
Denosumab biosimilars approved in Canada to expand access for osteoporosis and cancer-related bone conditions
- By IPP Bureau
| April 24, 2026
Biocon Limited has been granted a Notice of Compliance (NOC) by Health Canada for its denosumab biosimilars—Bosaya™ (denosumab), referencing Prolia®, and Vevzuo™ (denosumab), referencing Xgeva®.
The approvals were granted on April 3, 2026, marking a key regulatory milestone for the company as it strengthens its presence in global biosimilars markets.
Both products have been approved in commonly used formulations. Bosaya™ is approved as a 60 mg/mL injection for subcutaneous use in a prefilled syringe, while Vevzuo™ is approved as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.
Denosumab therapies are widely used in bone health management, including the treatment of osteoporosis and prevention of skeletal complications associated with cancer, playing an important role in improving patient outcomes across multiple disease areas.
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, while further strengthening our portfolio of affordable biologic therapies across immunology and oncology,” Tambe added.
