Sandoz Canada receives Health Canada regulatory approval for (Pr)Sandoz® Semaglutide, a generic version of (Pr)Ozempic®

• ^PrSandoz^® Semaglutide, a generic version of ^PrOzempic^®, approved for the treatment of adult patients with type 2 diabetes
• This lower-cost alternative supports improved affordability and access to type 2 diabetes treatments across Canada
• An important milestone in further strengthening Sandoz Canada's established diabetes portfolio

SAINT-HUBERT, QC, Sept. 18, 2026 /CNW/ -- Sandoz Canada Inc. today announces that Health Canada has granted authorization to market ^PrSandoz^® Semaglutide, a generic version of Novo Nordisk's ^PrOzempic^®, bringing Canadian patients one step closer to greater access. ^PrSandoz^® Semaglutide has been approved for the once-weekly treatment of adult patients with type 2 diabetes to improve glycemic control, in combination with lifestyle changes and other antidiabetic agents¹.

The generic version of semaglutide is a complex synthetic product that is pharmaceutically equivalent to the brand name biologic drug. The Notice of Compliance was issued for three doses delivered subcutaneously via two pen presentations: a pen delivering 0.25 mg or 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]).

"We are delighted to have received a Notice of Compliance for ^PrSandoz^® Semaglutide, a treatment for people living with type 2 diabetes – a condition that affects many Canadians," says Michel Robidoux, President and General Manager of Sandoz Canada. "Sandoz Canada continues to strengthen its diabetes portfolio with the upcoming launch of this product. With close to 12 million semaglutide injection pens used annually in Canada² and considering the significant increase in demand for this product, we aim to reduce barriers to access, both financially and in terms of supply."

Following Health Canada's regulatory approval, Sandoz Canada is taking the necessary steps to prepare for the future commercialization of ^PrSandoz^® Semaglutide.

To support the introduction of generic semaglutide treatments in Canada, Sandoz Canada is developing educational materials and practical tools designed to support patients and healthcare professionals throughout their treatment journey.

This milestone reinforces the Sandoz Purpose of pioneering access for patients and reflects the company's continued commitment to expanding its portfolio of diabetes treatments. As a leader in affordable medicines, Sandoz Canada continues to work with healthcare partners to support sustainable healthcare systems and improved patient outcomes.

^*PrOzempic^® is a registered trademark of Novo Nordisk A/S

ABOUT ^PrSANDOZ^® SEMAGLUTIDE

Sandoz Semaglutide is indicated for the once-weekly treatment of adult patients with type 2 diabetes to improve glycemic 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 glycemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic 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 glycemic control; basal insulin with metformin, when diet and exercise plus basal insulin with metformin do not achieve adequate glycemic control¹.

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. Data on file. Based on IQVIA CDH 2025 data (UN)

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 of the control of Sandoz. Should one or more of these risks or uncertainties materialize 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.

ABOUT SANDOZ CANADA

As a Canadian leader in off-patent medicines, Sandoz Canada has a product portfolio that includes over 700 generics and biosimilars spanning multiple therapeutic areas, such as anti-infective, cardiovascular, central nervous system, diabetes, immunology and oncology. In 2025, 59 million Sandoz prescriptions were issued in Canada (source: IQVIA Compuscript TRx, MAT 2025). Sandoz Canada employs 300 people across the country and at its head office in Saint-Hubert, Quebec. It is a trusted partner for pharmacists, physicians and hospitals for quality medicine and outstanding customer service and is committed to ensuring a reliable supply. For more information about Sandoz Canada, visit www.sandoz.ca.

SOURCE Sandoz Canada

CONTACTS: Media relations contact: [email protected], Sophie Levasseur, Manager, Corporate Communications, [phone]