Health Canada Hit 180-Day Generic Target 84% of Time in FY25

The regulator authorized a second generic semaglutide injection on May 1, 2026, filed by Canadian-based Apotex, and confirmed it is currently reviewing seven other submissions for generic semaglutide from different companies [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html]. The department said regulatory decisions on more of these submissions are expected in the coming weeks and months [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

The backlog behind the queue

The Canadian Generic Pharmaceutical Association said more than 500 generic submissions were under review at Health Canada, of which more than 100 were backlogged [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Association president Jim Keon said in a November statement that the federal budget tabled that month did not direct new resources at Health Canada to the problem, even though most of the work is paid for by industry fees [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

In most cases where Health Canada hit the 180-day target, applications were rejected within days of the deadline and then accepted after further review [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Seven drug manufacturers have so far filed for generic semaglutide with Health Canada, the first in February 2024 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Sandoz: 'road longer than expected'

Sandoz Canada Inc., a subsidiary of Sandoz Group AG, filed its application in November 2024, and a year later is still answering questions from Health Canada about its submission [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Michel Robidoux, general manager of Sandoz Canada, said "the road to get this 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 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

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 from Health Canada [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Mark Johnson, a Health Canada spokesperson, said evaluating generic semaglutide drugs is more complex than many other medication approvals because semaglutide was originally developed using biological processes, while the generic versions can be made using more simple chemical means [Source: cbc.ca/news/health/ozempic-glp1-health-canada-generic-9.7034498].

Where the regulatory clock matters for pricing

Under the pan-Canadian Pharmaceutical Alliance tiered framework, a single-source generic enters at 85% of the brand reference price, or 75% if a pricing agreement with provincial plans exists, and automatically drops to 55% after three months of public funding [Source: endorhealth.com/article/generic-ozempic-approved-canada-prescription]. With two generics, the price for both falls to 50% of the brand reference price; with three or more generics, the price falls to 35% of the brand reference price for injectables like semaglutide [Source: endorhealth.com/article/generic-ozempic-approved-canada-prescription].

That means the speed at which Health Canada clears the remaining seven files directly influences when patients and plans see the deeper tier-two and tier-three discounts. Readers tracking dosing options can compare current listings for Ozempic, Wegovy, Rybelsus, Mounjaro and Zepbound, and monitor authorizations on our generic semaglutide tracker.

Political response

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" [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Prime Minister Mark Carney's election platform in April promised to speed up drug approvals in Canada [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Health Canada said generally the department is working to modernize drug-approval regulations and that more complex submissions can take longer [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

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