Health Canada Approves Sandoz Generic Semaglutide, Opening Canada's USD 2.6 Billion GLP-1 Market
核心洞察
Health Canada has granted marketing authorisation to Sandoz Semaglutide, a generic GLP-1 receptor (搜索) agonist injection referencing Novo Nordisk's Ozempic, for adults with type 2 diabetes (搜索).
The approval covers once-weekly subcutaneous dosing in three strengths across two pen presentations, including 0.25 mg and 0.5 mg pens and a 1 mg pen.
Sandoz frames the move as an access milestone in a Canadian GLP-1 market worth an estimated USD 2.6 billion, with nearly 12 million semaglutide injection pens used annually.
Sandoz announced on 18 September 2026 that Health Canada has granted marketing authorisation for Sandoz® Semaglutide, a GLP-1 receptor (搜索) agonist injection and a generic version of Ozempic®, for the once-weekly treatment of adults with type 2 diabetes (搜索) mellitus to improve glycaemic control. The Basel-based company said the approval is an important step toward expanding patient access to an affordable semaglutide option in Canada and supporting the local healthcare system.
Approval Details and Dosing
Semaglutide has been approved in Canada for once-weekly administration as a subcutaneous injection in adult patients with type 2 diabetes (搜索) mellitus to improve glycaemic control. It will be available in three dose strengths delivered via two pen presentations: a pen delivering 0.25 mg and 0.5 mg doses (containing 2 mg of semaglutide [1.34 mg/mL]) and a pen delivering 1 mg doses (containing 4 mg of semaglutide [1.34 mg/mL]).
The indication covers use in combination with diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance; with metformin when diet and exercise plus maximal tolerated metformin do not achieve adequate glycaemic control; with metformin and a sulfonylurea when dual therapy fails to achieve adequate control; with metformin or a sulfonylurea plus a sodium-glucose cotransporter 2 inhibitor (SGLT2i) when those regimens do not achieve adequate glycaemic control; and with basal insulin plus metformin when that combination does not achieve adequate glycaemic control.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that lowers blood glucose by stimulating insulin secretion and reducing glucagon release in response to elevated blood glucose levels.
A Market of USD 2.6 Billion
The regulatory decision lands in a Canadian GLP-1 market estimated to be worth USD 2.6 billion, with close to 12 million semaglutide injection pens issued annually in the country, according to data on file based on full-year 2025 IQVIA MAT data and IQVIA CDH MAT June 2026 data.
Sandoz Chief Executive Officer Richard Saynor framed the approval within a broader access agenda: "GLP-1s represent one of the most significant access opportunities in modern healthcare. As demand for these medicines continues to rise globally, Sandoz remains focused on bringing affordable treatment options that expand access to patients and support the sustainability of healthcare systems. With this approval, we are advancing that ambition and our overall GLP-1 strategy."
Keren Haruvi, Sandoz President, North America, added: "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."
Diabetes Burden in Canada
Nearly six million Canadians live with diabetes, with type 2 accounting for approximately 90–95% of cases, according to the Public Health Agency of Canada. Overall diabetes prevalence is expected to increase to 7.3 million by 2034, per Diabetes Canada's 2024 backgrounder. If not properly controlled, the disease can lead to serious long-term complications, including vision loss, chronic kidney disease, cardiovascular events such as heart attack and stroke, and diabetes-related foot complications, according to the World Health Organization.
Broader GLP-1 Strategy
The Canadian authorisation builds on recent Sandoz GLP-1 milestones, including US Food and Drug Administration (搜索) acceptance of the company's applications for in-house development of generic tirzepatide GLP-1s and the approval of Owozy (搜索)™ (semaglutide) in Brazil, for which Sandoz holds commercial rights.
Sandoz describes itself as the global leader in affordable medicines, with a portfolio of approximately 1,300 medicines and a pipeline of more than 300 additional assets. The company reported net sales of USD 11.1 billion in 2025 and employs more than 20,000 people of 100 nationalities.
Sandoz said the approval has no impact on its financial guidance for 2026 and that it foresees no material contribution this year from any potential launches of generic semaglutide. Ozempic® is a registered trademark of Novo Nordisk A/S.