Health Canada Approves Second Generic Version of Ozempic, First by Canadian Manufacturer

Health Canada has approved a second generic version of the diabetes drug Ozempic, marking the first such product produced by a Canadian pharmaceutical company.

The semaglutide injection submitted by Canadian drugmaker Apotex was authorized after a review found it met federal safety, efficacy, and quality standards, according to a Health Canada news release. The generic drug will be administered as a once-weekly injection, consistent with existing semaglutide treatments.

Toronto-based Apotex focuses on generic medicines and operates manufacturing facilities in Canada, the United States, Mexico, and India. The company says it produces about 25 billion doses annually and exports to more than 115 countries.

The approval of Apo-Semaglutide Injection comes just days after Health Canada cleared the first generic version of the drug for sale in Canada, submitted by India-based Dr. Reddy’s Laboratories.

Semaglutide is marketed by Danish pharmaceutical company Novo Nordisk under the brand name Ozempic for the treatment of Type 2 diabetes and chronic obesity.

Canada is the first G7 country to authorize the sale of generic semaglutide products.

Health Canada says generic drugs are typically 45 to 90 percent cheaper than brand-name versions, with prices expected to decline further as more competitors enter the market.

The department said it is currently reviewing seven additional generic semaglutide submissions, with decisions expected in the coming weeks and months. It added that its review timelines are shorter than those of many international regulators.

Health Canada targets about 180 days for standard generic drug reviews. By comparison, the U.S. Food and Drug Administration typically takes about 10 months, while the European Medicines Agency’s process can extend to 12 to 15 months when pauses are included. The United Kingdom’s Medicines and Healthcare products Regulatory Agency has a standard timeline of around 210 days.

Demand for semaglutide-based drugs has surged in recent years amid rising rates of obesity and diabetes worldwide.

According to the World Health Organization, global obesity has more than doubled since 1990, with roughly 43 percent of adults overweight or obese. By 2022, diabetes cases had increased to affect more than 800 million people globally, including 160 million children and adolescents, due to trends linked to diet, physical inactivity, and broader lifestyle factors.

In Canada, adult obesity has risen from about 20.6 percent in the early 2000s to more than 28 percent in recent years, with roughly two-thirds of adults now classified as overweight or obese, according to federal data. Diabetes rates have also climbed steadily, with nearly 4 million Canadians—about one in 10—living with the condition. Public health officials say rising obesity remains a key driver of diabetes and other chronic diseases.