Drug companies in Canada are allowed to make lower priced generic versions of the blockbuster drug Ozempic as of next week, but experts say patients shouldn’t expect it to be available for at least a few months.
As of Dec. 29, Health Canada had received nine submissions seeking approval to make semaglutide, the active ingredient in Ozempic and Wegovy, the brand-name diabetes and weight-loss drugs manufactured by Novo Nordisk.
“Health Canada understands that there is considerable interest in lowering costs associated with this highly prescribed drug by introducing generic versions,” spokesperson Mark Johnson said in an email to The Canadian Press.
Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada have all applied for Health Canada authorization, according to its list of generic submissions.
Sandoz Canada and Teva Canada told The Canadian Press they couldn’t provide any information on expected timelines for their products, while the others either could not be reached or did not respond to requests for comment.
The remaining companies weren’t named because their submissions were received prior to April 1, 2024, when the policy requiring a sponsor name changed, Johnson said.
Mina Tadrous, a pharmaceutical policy expert at the University of Toronto, said a generic semaglutide medication is unlikely to be approved until late spring or early summer.
“Canadians should not be expecting a product in January,” he said.
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Based on generic pricing models in Canada, patients can expect the drug to be priced as low as 35 per cent of the brand-name Ozempic cost, which can be a few hundred dollars a month, Tadrous said, noting that there will likely be multiple generic semaglutide medications competing with each other.
The “target timeline” for Health Canada’s scientific review of generic drug submissions is 180 days, Johnson said.
That doesn’t include the extra time required if Health Canada needs more information from the drug company.
Evaluating generic semaglutide drugs is more complex than many other medication approvals, he said.
That’s because semaglutide was originally developed using biological processes, but the generic versions can be made using more simple chemical means.
“Generic semaglutide products are complex synthetic products that are pharmaceutically equivalent to the brand name drug, but with possible differences that could impact safety and efficacy,” Johnson said.
“The manufacturer must show that these differences do not affect the safety, efficacy, or quality of the drug compared to the brand name drug.”
Dr. Ehud Ur, an endocrinologist in Vancouver, said being able to prescribe generic semaglutide will be “very exciting,” noting that semaglutide would be an effective medication for many of his patients, but they aren’t on it because they can’t afford it.
“The price could drop pretty sharply and become quite affordable for people with Type 2 diabetes and obesity,” he said.
“I would say that the biggest barrier to (taking) Ozempic is not side effects or worries about its efficacy but its cost,” Ur said.
“When you’re talking about two, three, four hundred dollars a month, (for) a lot of people, you know, that is just impossible.”
Ur said generics should “theoretically” be the same as the brand name, but occasionally patients don’t have as good a response to generic medications so may decide to stay with the original.
Canada is the only country where Novo Nordisk allowed the patent for its semaglutide drugs to expire, paving the way for “regulatory exclusivity” to end on Jan. 4.
In an interview with The Canadian Press in late December, Novo Nordisk Canada president Vince Lamanna declined to give any details about the patent lapse, citing intellectual property confidentiality.
Lamanna said more than a million patients in Canada are taking the brand-name medications.
“Irrespective of what happens in January or through 2026, we’re committed to supporting patients on semaglutide — and that includes both Ozempic and Wegovy — and to continuing to make it available,” he said, noting that the company will provide “financial and savings support” to some patients who don’t have insurance coverage and don’t want to switch to a generic version.
Eli Lilly, Novo Nordisk’s main competitor for diabetes and weight loss medication, still holds its patent in Canada and there’s no imminent patent expiry for its drugs: Mounjaro and Zepbound.
The active ingredient in those drugs is tirzepatide, which like semaglutide acts on glucagon-like peptide-1 (GLP-1) hormone receptors, but also targets glucose-dependent insulinotropic polypeptide (GIP) receptors.
“Lilly remains confident in the differentiated benefits of tirzepatide, the first and only dual GIP/GLP-1 receptor agonist approved to treat adults with obesity and adults with type two diabetes,” the company said in an email statement to The Canadian Press.
The statement did not address questions about whether or not Eli Lilly would provide cost savings to patients in order to compete with generic semaglutide.
