Biocon Denosumab Biosimilars Strengthens Global Push Drug Approval

Biocon denosumab biosimilars have secured a major regulatory win, with Health Canada granting a Notice of Compliance (NOC) for two of the company’s products—Bosaya and Vevzuo—on April 3, 2026.

The approval marks a significant step as Biocon strengthens its footprint in global biosimilars markets and expands access to critical bone health therapies.

Bosaya (denosumab), referencing Prolia, has been approved as a 60 mg/mL injection for subcutaneous use in a prefilled syringe.

Vevzuo (denosumab), referencing Xgeva, received approval as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. These commonly used formulations are expected to support easier administration and broader patient access.

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Denosumab therapies play a key role in managing bone health conditions. They are widely used for treating osteoporosis and preventing skeletal-related complications linked to cancer. With rising demand for effective and affordable biologic treatments, the approval of these biosimilars is expected to improve patient outcomes across multiple disease areas.

Commenting on the development, 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.

The Biocon denosumab biosimilars approval highlights the company’s growing capabilities in biologics and reinforces its strategy to deliver cost-effective therapies worldwide.