Health Canada Backlog Tops 500 Files as Semaglutide Queue Sits at 7

The Canadian Generic Pharmaceutical Association says more than 500 generic drug submissions are currently under review at Health Canada, with more than 100 of them backlogged, even as seven generic semaglutide files remain in the queue behind approvals already granted to Dr. Reddy's Laboratories and Apotex.

Where the semaglutide queue stands

Health Canada authorized a second generic semaglutide injection from Apotex, a Canadian-based generic manufacturer, and confirmed that seven other submissions for generic semaglutide from different companies remain under review. The department said it expects to make regulatory decisions on more of these submissions in the coming weeks and months.

Canada became the first G7 country to approve a generic version of semaglutide on April 28, 2026, following India's approval in March 2026. The generic version from Dr. Reddy's became available in Canada on May 15, while the Apotex version does not yet have a release date.

The 180-day target and the backlog

Health Canada has a target of responding to all generic drug submissions within 180 days, but hit that target only 84 per cent of the time in the fiscal year that ended March 31. The Globe and Mail reported that in most cases where the target was hit, applications were rejected within days of the 180-day deadline and then accepted after further review.

The Canadian Generic Pharmaceutical Association said it was disappointed that no new resources at Health Canada were being directed to the backlog in the federal budget tabled this month, especially as most of the work is paid for by industry fees. CGPA president Jim Keon said in a statement earlier in November that every day of delay in approving these medicines costs the health care system millions and denies drug plans the savings needed to fund new treatments.

What generic applicants are saying

Sandoz Canada Inc. filed its application in November 2024, and a year later the company is still answering questions from Health Canada about its submission. Michel Robidoux, general manager of Sandoz Canada, said the road to get the drug approved is probably longer than expected and that the industry is not expecting generic semaglutide to have a major place in the Canadian market until mid-2026.

Dr. Reddy's Laboratories, which submitted to Health Canada in February or March last year, disclosed publicly that it had received a notice of non-compliance from Health Canada indicating the company still had further questions to answer about its submission. Health Canada has requested more data than it would on a more standard generic submission, in part because semaglutide is a more complicated pharmaceutical product.

Pricing implications

Mina Tadrous, a pharmacist who studies drug policy at the University of Toronto, told The BMJ that once three generic versions hit the market, the pricing framework will allow them to be substantially cheaper, with out-of-pocket costs dropping to around 35 per cent of the brand-name price, or roughly $C100 per month. Health Canada notes that many generic medications are 45 to 90 per cent cheaper than brand-name versions.

Current pharmacy prices tracked on GLP1Prices.ca show Ozempic ranging from $86.40 to $663 CAD, Wegovy from $270 to $550 CAD, and Mounjaro from $271.62 to $800 CAD. Readers tracking the pending files can follow updates through our generic semaglutide tracker and check plan rules via the insurance coverage checker.

The Health Canada registry

The public generic submissions registry lists individual applicant names, therapeutic class, and month of acceptance into review. Health Minister Marjorie Michel's office, through spokesperson Guillaume Bertrand, said the approval process currently takes too long, with bureaucracy getting in the way of delivering essential medications to Canadians who need them.

See also our pages for Rybelsus and Zepbound, along with our FAQ.

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

Sources

• Health Canada approval backlog expected to push back ...
• Canada approves second generic semaglutide, the first G7 ...
• Ozempic generic approved in Canada after Novo Nordisk ...
• Generic submissions under review