Sandoz Cites Brazil Priority Review as Canada Wait Stretches On

Sandoz Canada says the road to a Canadian generic semaglutide approval is taking longer than the company expected, with Health Canada still asking questions about a submission filed in November 2024 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

One year in, still answering questions

Michel Robidoux, general manager of Sandoz Canada Inc., a subsidiary of Sandoz Group AG, told The Globe and Mail that the company filed its semaglutide application in November 2024 and a year later is still answering questions from Health Canada about the submission [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Robidoux said the industry is not expecting generic semaglutide to have a major place in the Canadian market until mid-2026, though he cautioned that could change [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

The Sandoz filing is one of several queued behind brand-name Ozempic and Wegovy. Seven drug manufacturers had filed with Health Canada, the first in February 2024 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

The Brazil contrast

Robidoux pointed to Brazil, where Ozempic's patent runs out in March. Brazil's health regulator proactively notified drugmakers, including Sandoz, three months earlier that it would prioritize submissions for generic semaglutide because of the drug's high uptake and to help ensure a consistent supply [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. According to Novo Nordisk, more than a million people in Canada currently take a semaglutide drug [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/].

The backlog by the numbers

Health Canada has a target of responding to all generic submissions within 180 days, but it hit that target only 84 per cent of the time in the fiscal year that ended March 31, and in most cases where the target was hit, 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/].

The Canadian Generic Pharmaceutical Association said more than 500 generic submissions were under review, of which more than 100 were backlogged [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. 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, 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/].

Political response

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/]. A spokesperson for Health Minister Marjorie Michel, 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/]. The federal budget tabled in November did not mention the issue, and the CGPA said it was disappointed no new resources at Health Canada were being directed to the problem [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Where the file stands now

Health Canada on May 1, 2026 authorized a second generic semaglutide injection, filed by Canadian-based Apotex as a generic version of brand-name Ozempic, 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]. The department said it is currently reviewing seven other submissions for generic semaglutide by different companies and expects to make regulatory decisions on more of these submissions 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].

Obesity Canada Scientific Director Dr. Sanjeev Sockalingam wrote that fewer than 20 per cent of Canadians with private drug benefit plans have access to Health Canada-approved obesity treatment medications, and noted estimates that untreated obesity cost Canada $27.6 billion in 2023 [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/].

Canadians can track approval movement using the generic semaglutide tracker, review plan terms with the insurance coverage checker, and find background on tirzepatide products such as Mounjaro and Zepbound, or the oral semaglutide product Rybelsus, on our drug pages.

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