- Health Canada has granted NOC to Bosaya (denosumab) and Vevzuo (denosumab), biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively
- Developed by Biocon, the approvals cover key indications across osteoporosis and cancer-related bone complications, including bone metastases and skeletal-related events
- The therapies are available in standard SC formats (Bosaya prefilled syringe; Vevzuo single-dose vial) and are supported by analytical, nonclinical, and clinical data showing no meaningful differences vs reference biologics
- With osteoporosis affecting >2M Canadians and bone complications common in advanced cancers, the approvals aim to expand access to high-quality, cost-effective biologic therapies
Takeaways:
Bosaya and Vevzuo, layered on top of other recent denosumab biosimilar launches, should accelerate formulary switches and tender competition, strengthen Biocon’s credibility as a global biologics player, and turn Canada into an early reference market for denosumab biosimilar uptake strategies that can later be replicated in the US and EU.
Source: Businesswire
