Biocon Gets Health Canada Approval for Bosaya and Vevzuo Biosimilars for Bone Diseases

Biocon Receives Health Canada Approval of Bosaya™ (Denosumab) and Vevzuo™ (Denosumab), Biosimilars to Prolia® and Xgeva® 

Biocon Limited, a leading global biopharmaceutical innovator, announced Health Canada's approval of Bosaya, a biosimilar to Prolia, and Vezuo (denosumab), a biosimilar to Xgeva. BOSAYA is approved as a 60 mg/mL injection in prefilled syringes for subcutaneous use, and VEVZUO as a 120 mg/1.7 mL (70 mg/mL) single-dose subcutaneous vial. 

CEO & Managing Director, Biocon Ltd., Shreehas Tambe, said, "It marks an important milestone for Biocon as we continue to expand access to high-quality biosimilars in key global markets." This reflects our strong scientific and regulatory capabilities, reinforcing our commitment to patients living with osteoporosis and cancer-related bone conditions. 

According to Towards Healthcare, the Biosimilar Antibodies market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 44.31 billion in 2026 to approximately USD 153.46 billion by 2035, representing a compound annual growth rate (CAGR) of 14.8% from 2026 to 2035. Growth is driven by the increasing prevalence of chronic diseases globally, which in turn drives the demand for biosimilars as cost-effective treatment options. It also contributes to the robust growth of the biosimilar antibodies market, presenting significant opportunities for market players in the years to come.  

About BOSAYA (denosumab) 

BOSAYA has been approved by Health Canada specifically for osteoporosis treatment in postmenopausal women and men at high risk for fracture, as well as for bone loss conditions related to certain cancer therapies. Its indication focuses on osteoporosis and related bone loss, distinguishing it from oncology-specific uses.  

About VEVZUO (denosumab) 

Vevzuo (denosumab) is a biosimilar medicine used to prevent bone complications in adults with advanced cancer that has spread to the bone. It is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed. It contains the active substance denosumab and is a biological medicine. This means that Vevzuo is highly similar to another biological medicine that is already authorised in the EU. 

A recent report by Towards Healthcare highlights that the Biosimilar Antibodies market is witnessing growth factors such as patent expirations and the increasing demand for cost-effective therapeutic options. The market is led by large, integrated pharmaceutical and biotechnology companies, with investment activity focusing on strategic alliances, mergers, and acquisitions to increase market share and secure global commercialisation rights. 

North America is expected to dominate the market while Asia Pacific is projected to grow at the fastest, driven by the increasing prevalence of chronic disorders, the cost-effectiveness of biosimilar drugs, and the need for more affordable therapeutic alternatives.