Novo Nordisk: More Than 1 Million Canadians Take Semaglutide

The patient-count figure surfaced in coverage of the Health Canada generic semaglutide approval pipeline, where Sandoz Canada and other applicants are still answering regulator questions more than a year after filing [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Semaglutide is the active ingredient in Ozempic, Wegovy and Rybelsus.

Two generics cleared, seven more under review

Health Canada authorized the first generic semaglutide injection, filed by Dr. Reddy's Laboratories, on April 28, 2026, making Canada the first G7 country to do so [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. On May 1, 2026, the department authorized a second generic semaglutide injection, filed by Canadian-based Apotex, and said it was reviewing seven other submissions for generic semaglutide by different companies [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Both authorizations are indicated for the once-weekly treatment of adult patients with type 2 diabetes to manage blood sugar levels [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

CGPA: more than 500 generic submissions in 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 "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, which is not in the interests of Canadian taxpayers, employers, and patients" [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Health Canada has a target of responding to all such submissions within 180 days, and hit that target 84 per cent of the time in the fiscal year ended March 31 [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 semaglutide 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 "So we are working very hard, but the road to get this drug approved is probably longer than expected" [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Robidoux acknowledged that chemical complexity is adding to regulatory complications for the synthesized versions of semaglutide that Sandoz and other companies are proposing, and that Health Canada has requested more data than it would on a more standard generic submission [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Federal 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/]. 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/].

The CGPA said it was disappointed no new resources at Health Canada were being directed to the problem in the federal budget, especially as 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/].

What it means for Canadian patients

Canadians tracking access can follow updates on our generic semaglutide tracker, check plan rules with the insurance coverage checker, or review common questions in our FAQ. Tirzepatide products Mounjaro and Zepbound remain on a separate regulatory and patent timeline.