Seven Generic Semaglutide Files Remain in Health Canada Queue

Health Canada is currently reviewing seven additional generic semaglutide injection submissions following its authorization of a second generic version from Apotex, with regulatory decisions expected in the coming weeks and months.

Where the queue stands

Canada became the first G7 country to authorize a generic version of semaglutide on April 28, 2026, when Health Canada cleared the submission from India's Dr. Reddy's Laboratories, sold in India under the brand name Obeda. The second authorization went to Canadian-based Apotex, whose product is a generic version of the brand name drug Ozempic from Novo Nordisk.

Health Canada has stated that it will continue to monitor all authorized generic semaglutide products and will take appropriate action should any unexpected safety or effectiveness concerns arise.

Backlog context

The regulator has been working through a historic backlog of generic drug submissions. In the fiscal year that ended March 31, Health Canada hit its 180-day response target 84 per cent of the time, and in many of those cases the applications were rejected within days of the deadline and only accepted after further review.

The Canadian Generic Pharmaceutical Association reported that more than 500 generic submissions were under review, of which more than 100 were backlogged, according to a statement from association president Jim Keon. Seven drug manufacturers had filed semaglutide submissions with Health Canada, the first in February 2024.

Government response

Health Minister Marjorie Michel's office said it is working on the approval timelines issue, with spokesperson Guillaume Bertrand stating that the approval process currently takes too long and that bureaucracy is getting in the way of delivering essential medications to Canadians. Health Canada said the department is working to modernize drug-approval regulations and that more complex submissions can take longer.

Pricing framework

Under the pricing structure of the pan-Canadian Pharmaceutical Alliance, the first generic medication could cost 75 to 85 per cent of the brand name, according to Mina Tadrous, a pharmaceutical policy expert at the University of Toronto. Once a second product enters the market, the price for both drops to 50 per cent, and when three or more generic products are available, the cost would decrease to about 35 per cent of brand-name Ozempic's price.

Health Canada has noted that many generic medications are 45 to 90 per cent cheaper than the brand name versions. Current pharmacy prices tracked on GLP1Prices.ca show brand-name Ozempic ranging from $86.40 to $663 CAD, while Wegovy ranges from $270 to $550 CAD and Rybelsus ranges from $230 to $293.99 CAD. Tirzepatide products from Eli Lilly, Mounjaro and Zepbound, remain outside the semaglutide generic pathway.

What to watch

Health Canada publishes submissions accepted for review on its Submissions Under Review list, and the department expects to make regulatory decisions on more of the pending semaglutide files in the coming weeks and months. Readers tracking which applicants remain active can follow our generic semaglutide tracker, verify plan details through our insurance coverage checker, or review common questions in our FAQ.

This article is for informational purposes only and does not constitute medical advice.

Sources

• Canada approves second generic semaglutide, the first G7 ...
• Health Canada approves country's 1st generic version of ...
• Health Canada approval backlog expected to push back ...
• Generic submissions under review