Health Canada Registry: Six Generic Semaglutide Files Pending

Health Canada's public registry of generic submissions under review continues to list generic semaglutide files behind the two products already authorized this year, with the department confirming on June 29, 2026 that six additional submissions remain in the queue.

What the registry shows

The federal "Generic submissions under review" page is the official public list of pending applications for generic products in Canada. In its June 29, 2026 news release announcing authorization of Apotex's Sevmia -- a generic version of the brand-name drug Wegovy for chronic weight management in patients 12 years and over -- Health Canada stated it was reviewing six other submissions for generic semaglutide from different companies, and expected further regulatory decisions in the coming weeks and months.

How the queue built up

Seven manufacturers had filed generic semaglutide applications with Health Canada, with the first submission arriving in February 2024, according to reporting on the pre-approval landscape. Sandoz Canada Inc., a subsidiary of Sandoz Group AG, filed its application in November 2024 and was still answering Health Canada questions a year later, general manager Michel Robidoux said.

Robidoux said the road to approval was probably longer than expected, and noted the industry did not expect generic semaglutide to have a major place in the Canadian market until mid-2026. Dr. Reddy's Laboratories Ltd., which submitted to Health Canada in February or March of last year, disclosed publicly that it had received a notice of non-compliance indicating the company still had further questions to answer.

Backlog context

Health Canada has a target of responding to all generic drug submissions within 180 days, and hit that target 84 per cent of the time in the fiscal year that ended March 31, according to data reported by The Globe and Mail. The Canadian Generic Pharmaceutical Association said more than 500 generic submissions were under review, of which more than 100 were backlogged, and association president Jim Keon expressed disappointment that no new Health Canada resources were being directed to the problem.

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.

Pricing implications

Health Canada has said many generic medications are 45 to 90 per cent cheaper than brand-name versions. Under the pan-Canadian Pharmaceutical Alliance pricing structure, the first generic medication could cost 75 to 85 per cent of the brand name; once a second medication enters the market, the price for both drops to 50 per cent; when there are three or more generic products available in Canada, the cost would decrease to about 35 per cent of brand-name Ozempic's price, according to Mina Tadrous, a pharmaceutical policy expert at the University of Toronto.

Current cash prices tracked on GLP1Prices.ca for Ozempic range from CAD $86.40 to $663 across surveyed pharmacies, while Wegovy ranges from CAD $113 to $550. Tirzepatide products Mounjaro and Zepbound are not affected by the semaglutide submissions queue.

What to watch

• Additional decisions on the six pending semaglutide files flagged by Health Canada.
• Follow-up filings and refilings visible on the public submissions registry.
• Whether federal action follows the Health Minister's office statement on cutting red tape.

Readers tracking approvals as they land can follow our generic semaglutide tracker, check the insurance coverage checker, or consult the FAQ for definitions of terms such as notice of non-compliance.

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

Sources

• canada.ca
• canada.ca
• theglobeandmail.com
• globalnews.ca