Canada has authorized a second generic version of the blockbuster diabetes drug Ozempic and for the first time, the product comes from a Canadian company. Health Canada confirmed this week that Toronto-based Apotex received federal approval for its semaglutide injection, branded as Apo-Semaglutide Injection, after regulators determined it met all required standards for safety, efficacy, and quality.
The news follows closely on the heels of last week’s approval of the first-ever generic semaglutide in Canada, submitted by India’s Dr. Reddy’s Laboratories. Together, the two authorizations cement Canada’s place as the first G7 nation to open its market to generic versions of semaglutide a distinction that carries real significance for patients who have long struggled to access the drug due to its steep cost.
Semaglutide, sold by Danish pharmaceutical giant Novo Nordisk under the Ozempic brand, has become one of the most talked-about medications in recent memory. Originally developed to treat Type 2 diabetes, it gained a second life as a treatment for chronic obesity after studies showed significant weight-loss results. Demand has been relentless and supply hasn’t always kept pace, leaving pharmacies with shortages and patients paying out of pocket for what is, for many, an essential medication.
Apotex, a well-established name in Canada’s generic drug industry, says it produces roughly 25 billion doses of various medications annually and ships to more than 115 countries from facilities across Canada, the United States, Mexico, and India. The newly approved injection will be administered once a week mirroring the dosing schedule of the branded version and is expected to offer a significantly more affordable alternative to Ozempic.
Health Canada noted that its review timeline is notably faster than those of peer regulators. The department typically clears standard generic drug applications within about 180 days. The U.S. Food and Drug Administration generally takes around ten months for similar reviews, while the European Medicines Agency’s process can stretch to well over a year once procedural pauses are factored in. The U.K.’s regulator sits at roughly 210 days. That comparative speed could give Canada an edge as pharmaceutical companies worldwide race to bring generic semaglutide to market.
Seven more generic semaglutide submissions are currently under review, with decisions expected in the coming weeks and months. As that field grows, Health Canada anticipates pricing will decline even further potentially making semaglutide accessible to a much broader slice of the population than current Ozempic pricing allows.
The urgency behind that accessibility is hard to overstate. Global rates of both obesity and diabetes have climbed steadily for decades. The World Health Organization reports that roughly 43 percent of adults worldwide are now overweight or obese, and that diabetes has come to affect more than 800 million people globally including 160 million children and adolescents. In Canada specifically, adult obesity has risen from around 20.6 percent in the early 2000s to more than 28 percent today, with nearly two-thirds of adults falling into the overweight or obese category. Close to four million Canadians about one in ten live with diabetes, a rate public health officials attribute in large part to rising obesity and shifting lifestyle patterns.
For those patients, cheaper semaglutide cannot come soon enough.
