Sandoz receives regulatory approval for generic semaglutide in Canada, paving way to expand patient access to key GLP-1 medicine

• Potential to expand patient access to semaglutide treatment option in Canada and support local healthcare system
• Builds on recent Sandoz GLP-1 milestones: tirzepatide FDA file acceptance in US and semaglutide regulatory approval in Brazil
• 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 USD 2.6 billion; close to 12 million semaglutide injection pens issued annually
   

Basel, 18 September 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announces that Health Canada has granted marketing authorisation for Sandoz^® Semaglutide (semaglutide), a GLP-1 receptor agonist injection and a generic version of Ozempic^®*.
The approval marks an important step towards expanding patient access to an affordable semaglutide treatment option in Canada and supporting the local healthcare system. It also builds on recent Sandoz GLP-1 milestones, including the recent US Food and Drug Administration acceptance of the Company’s applications for in-house development of generic tirzepatide GLP-1s and the approval of Owozy™ (semaglutide) in Brazil, for which Sandoz has commercial rights.
Richard Saynor, Sandoz Chief Executive Officer, says: “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.”
Semaglutide has been approved in Canada for once-weekly administration as a subcutaneous injection in adult patients with type-2 diabetes mellitus to improve glycaemic control¹. 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]).
Keren Haruvi, Sandoz President, North America, says: “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.”
It is estimated that nearly six million Canadians live with diabetes², with type 2 accounting for approximately 90-95% of cases³. Overall diabetes prevalence is expected to increase to 7.3 million by 2034⁴. 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 complications⁵.
The regulatory approval comes in a GLP-1 market worth an estimated USD 2.6 billion⁶, with close to 12 million semaglutide injection pens used annually in Canada⁷. It underscores the Sandoz commitment to help millions of patients access biosimilar and generic medicines sustainably and affordably through a global portfolio of more than 1,300 medicines, supported by an industry-leading pipeline of over 300 additional assets.
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.
*Ozempic^® is a registered trademark of Novo Nordisk A/S
About Sandoz Semaglutide
Sandoz Semaglutide is indicated for the once-weekly treatment of adult patients with type-2 diabetes to improve glycaemic control, in combination with: diet and exercise in patients for whom metformin is inappropriate due to contraindication or intolerance; metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycaemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycaemic control; metformin or a sulfonylurea and a sodium-glucose cotransporter 2 inhibitor (SGLT2i), when diet and exercise plus metformin or a sulfonylurea, in addition to an SGLT2i, do not achieve adequate glycaemic control; basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycaemic control.
DISCLAIMER
This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside the control of Sandoz. Should one or more of these risks or uncertainties materialise or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.
REFERENCES
¹ Upon regulatory approval by Health Canada, the Product Monograph will be made publicly available through Health Canada's Drug Product Database (DPD) and can be accessed via the online search portal Search criteria - Drug Product Database online query
² Diabetes Canada. Diabetes in Canada. 2024 Backgrounder. Available at: 2024 Diabetes in Canada Backgrounder. [Last accessed September 2026]
³ Public Health Agency of Canada. Diabetes in Canada: An Interactive Report on Key Statistics. Available at: https://health-infobase.canada.ca/diabetes/. [Last accessed: September 2026]
⁴ Diabetes Canada. Diabetes in Canada. 2024 Backgrounder. Available at: 2024 Diabetes in Canada Backgrounder. [Last accessed September 2026]
⁵ World Health Organization. Diabetes Factsheet. Available at: Diabetes. [Last accessed: September 2026]
⁶ Data on file. Based on full year 2025 IQVIA MAT data
⁷ Data on file. Based on IQVIA CDH MAT June 2026 data (UN)
ABOUT SANDOZ
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion.
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