Home / Regulatory / Sandoz Canada Receives Health Canada Approval for Generic Semaglutide 

Sandoz Canada Receives Health Canada Approval for Generic Semaglutide 

  • Sandoz Canada has received Health Canada authorization for (Pr)Sandoz Semaglutide, a generic version of Novo Nordisk’s Ozempic, for once-weekly treatment of adults with type 2 diabetes alongside lifestyle changes and other antidiabetic medicines. 
  • The approval covers 0.25 mg, 0.5 mg and 1 mg doses delivered subcutaneously through two pen presentations. Sandoz describes semaglutide as a complex synthetic product pharmaceutically equivalent to the reference product. 
  • Sandoz says the product could support greater affordability and access to type 2 diabetes treatment in Canada, where nearly 12 million semaglutide injection pens are used annually, amid growing demand. 
  • Following the Notice of Compliance, Sandoz is preparing for future commercialization and developing educational materials and practical tools for patients and healthcare professionals.   

Takeaways:  

Sandoz Canada’s Health Canada authorization for PrSandoz Semaglutide, a generic version of Ozempic, gives the country its first lower‑cost semaglutide option for type 2 diabetes in a rapidly growing GLP‑1 market estimated at about USD 2.6 billion, with nearly 12 million semaglutide pens used annually. While Sandoz does not expect a material 2026 financial impact, the approval positions it to capture share among the roughly six million Canadians living with diabetes (most with type 2) as it prepares commercialization, pricing and educational support, potentially improving affordability and easing supply pressure on the branded product. 

Source: CA Newswire 

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