Sandoz received regulatory approval for generic semaglutide in Canada, paving way to expand patient access to key GLP-1 medicine.
The approval could help expand access to an affordable semaglutide treatment option for eligible patients in Canada.
It follows recent developments in Sandoz’s GLP-1 portfolio, including the US Food and Drug Administration’s acceptance of the company’s applications for internally developed generic tirzepatide products and regulatory approval for Owozy (semaglutide) in Brazil, where Sandoz holds the commercial rights.
In Canada, semaglutide has been authorised for a weekly injection in adults with type 2 diabetes to improve glycaemic control. The medicine will be available in three dose strengths across two pen formats:
- A pen delivering 0.25 mg and 0.5 mg doses, containing 2 mg of semaglutide at a concentration of 1.34 mg/mL.
- A pen delivering a 1 mg dose, containing 4 mg of semaglutide at the same concentration.
Nearly six million Canadians live with diabetes, of which type 2 accounts for approximately 90-95%; prevalence expected to rise to 7.3 million by 2034.
Canadian GLP-1 market worth is $2.6 billion (£1.95 billion) with close to 12 million semaglutide injection pens issued annually.
Keren Haruvi, Sandoz President, North America, said: “We believe medicines like semaglutide can transform outcomes for patients, but only if they are more broadly accessible. Millions of Canadians are currently living with diabetes, with prevalence only expected to rise.
“This milestone reinforces our commitment to bringing an affordable semaglutide treatment option to more people across Canada, taking us one step closer to expanding access to this important medicine.”
The approval has no impact on Sandoz financial guidance for 2026 and the Company foresees no material contribution this year from any potential launches of generic semaglutide.
