Generic Ozempic-style drugs could cut plan costs, but approvals may slip into late 2026
Canada is about to find out how much cheaper Ozempic-style drugs can really get – but any impact on plan costs will land later this year, not this quarter.
According to BNN Bloomberg, Health Canada can now approve lower-priced generic versions of semaglutide, the active ingredient in Ozempic and Wegovy, after “regulatory exclusivity” ended on January 4.
As of December 29, the regulator had nine generic semaglutide submissions, including filings from Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada.
Despite that, plan sponsors should not expect immediate relief.
Pharmaceutical policy expert Mina Tadrous of the University of Toronto said a generic semaglutide medication is unlikely to be approved before late spring or early summer and that “Canadians should not be expecting a product in January,” as reported by BNN Bloomberg.
Health Canada’s target review time for generics is 180 days. That does not include extra time if the regulator requests more data.
It views semaglutide generics as more complex to assess because they are “complex synthetic products.” They must still match the brand on safety, efficacy and quality, BNN Bloomberg reports.
The pricing stakes are material.
Based on Canadian generic pricing models, Tadrous said patients could see semaglutide priced as low as 35 percent of the current Ozempic cost, which he described as a few hundred dollars a month, and he expects several generic products to compete with one another, according to BNN Bloomberg.
That kind of discount, once volumes build, could significantly reduce GLP-1 spend for employer and retiree plans.
On the clinical side, cost remains the main access barrier.
Vancouver endocrinologist Ehud Ur said being able to prescribe generic semaglutide will be “very exciting,” noting that semaglutide would be effective for many of his patients but they do not take it because they cannot afford it, as per BNN Bloomberg.
He said “the biggest barrier to (taking) Ozempic is not side effects or worries about its efficacy but its cost,” pointing out that paying “two, three, four hundred dollars a month” is “just impossible” for many patients.
He added that generics should “theoretically” be the same as the brand, though some patients may still prefer to stay on the original, BNN Bloomberg reports.
Canada is also being watched internationally.
Bloomberg reports that Health Canada is currently reviewing nine generic semaglutide applications, including those from Sandoz Group and Reddy’s Laboratories, and that the regulator has told both companies their copycat versions do not yet meet requirements.
According to Bloomberg, Sandoz now expects generic semaglutide options to reach the Canadian market in the third quarter, and Canada is acting as a testing ground ahead of future patent expiries in markets such as China, India and Brazil.
Novo Nordisk is trying to hold on to its franchise as this shift unfolds.
BNN Bloomberg reports that Novo Nordisk Canada president Vince Lamanna said more than a million patients in Canada are taking Ozempic and Wegovy and that the company is committed to “supporting patients on semaglutide — and that includes both Ozempic and Wegovy.”
He said Novo Nordisk will offer “financial and savings support” to some patients without insurance who do not want to move to a generic, according to BNN Bloomberg.
Competition will remain a factor.
Eli Lilly, Novo Nordisk’s main rival in diabetes and weight loss drugs, still holds its patent in Canada for Mounjaro and Zepbound and faces no imminent patent expiry here.
The active ingredient tirzepatide targets both GLP-1 and GIP receptors, and Eli Lilly said it “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,” as reported by BNN Bloomberg.
