Biocon Limited has received a Notice of Compliance (NOC) from Health Canada for its biosimilar products Bosaya™ (denosumab) and Vevzuo™ (denosumab). Approved on April 3, 2026, these therapies provide new treatment options for over 2 million adults living with osteoporosis and those suffering from bone complications due to advanced cancer, marking a significant milestone in Biocon’s global expansion of affordable biologic therapies.
Strategic Approval for Oncology and Bone Health
Biocon Limited has announced the successful approval of its denosumab biosimilars by Health Canada. Bosaya™, a biosimilar to Prolia®, and Vevzuo™, a biosimilar to Xgeva®, have received clearance for their primary market presentations. The approvals include a 60 mg/mL prefilled syringe for Bosaya™ and a 120 mg/1.7 mL single-dose vial for Vevzuo™.
Expanding Access to Vital Therapies
These products are essential for bone health, targeting bone mass preservation and the management of skeletal-related events in cancer patients. According to Shreehas Tambe, CEO & Managing Director, this achievement reinforces Biocon’s scientific capabilities and its commitment to providing high-quality, affordable biologic therapies. The approvals address high unmet needs in both immunology and oncology, with potential benefits reaching millions of patients annually.
Indications and Treatment Scope
Bosaya™ is designated for postmenopausal women with osteoporosis at high fracture risk, as well as men with osteoporosis and those undergoing hormone-deprivation therapies for nonmetastatic cancers. Vevzuo™ is indicated for managing skeletal-related events in patients with multiple myeloma and various bone metastases from solid tumors, such as breast, prostate, and non-small cell lung cancer. It is also approved for treating hypercalcemia of malignancy that is refractory to intravenous bisphosphonate.
Clinical Foundation
The regulatory approval follows a comprehensive evaluation of analytical, nonclinical, and clinical data. Health Canada confirmed that both Bosaya™ and Vevzuo™ are highly similar to their reference products, with no clinically meaningful differences regarding quality, safety, or efficacy. These biosimilars function by targeting the Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) to reduce bone breakdown, effectively increasing bone mass and strength.
Source: BSE
