Biocon Ltd

🇨🇦 Health Canada Approves Two Biocon Biosimilars: Bosaya™ & Vevzuo™

• Health Canada approved biosimilars Bosaya™ (denosumab) and Vevzuo™ (denosumab) on April 3, 2026.

• Bosaya™ is a biosimilar to Prolia®, approved as a 60 mg/mL injection for subcutaneous use in a prefilled syringe.

• Vevzuo™ is a biosimilar to Xgeva®, approved as a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial.

• Approvals are based on analytical, nonclinical, and clinical data showing high similarity to reference products with no clinically meaningful differences.

• Bosaya™ is indicated for treating osteoporosis in high-risk postmenopausal women and men, and for bone mass increase in certain cancer patients on specific therapies.

• Vevzuo™ is approved for reducing skeletal-related events in patients with multiple myeloma or bone metastases from various cancers, and for treating giant cell tumor of bone and hypercalcemia of malignancy.

• The products target over 2 million adults with osteoporosis and hundreds annually with bone metastasis complications.

• Key warnings include risks of hypocalcemia, infections, osteonecrosis of the jaw, atypical femoral fractures, and hypersensitivity reactions.

• Biocon, headquartered in Bengaluru, India, has commercialized 12 biosimilar products and operates in over 120 countries.