Sandoz's Robidoux: Generic Semaglutide Road 'Longer Than Expected'

Sandoz still in review a year after filing

Sandoz Canada Inc., a subsidiary of Sandoz Group AG, submitted its generic semaglutide application to Health Canada in November 2024 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. According to general manager Michel Robidoux, the company is still responding to questions from the regulator about its submission [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Robidoux said competitors are in the same position and the industry does not expect 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/]. He 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/].

Health Canada backlog by the numbers

Health Canada has a target of responding to generic drug submissions within 180 days, but hit that target only 84 per cent of the time in the fiscal year ending March 31 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. In most cases where the target was hit, applications were rejected within days of the 180-day 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 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" [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Two generics cleared, seven still pending

Health Canada authorized the first generic semaglutide injection on April 28, 2026, a submission from Dr. Reddy's Laboratories referencing the brand-name drug Ozempic [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. Health Canada said it is currently reviewing eight other submissions for generic semaglutide and expects to make regulatory decisions on more of these submissions in the coming weeks and months [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

The BMJ reported that two generic versions of injectable semaglutide were approved by Health Canada in recent weeks — from India's Dr Reddy's Laboratories and Canadian company Apotex — with seven other applications still under review [Source: bmj.com/content/393/bmj-2026-597166]. The Dr Reddy's version became available in Canada on 15 May, while the Apotex version does not yet have a release date [Source: bmj.com/content/393/bmj-2026-597166].

Seven drug manufacturers have filed with Health Canada to date, the first in February 2024 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/]. Dr. Reddy's, which submitted in February or March of last year, recently disclosed it had received a notice of non-compliance from Health Canada, which indicated the company still had further questions to answer [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Federal budget did not address the backlog

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/]. Despite the campaign promise, the federal budget tabled this month did not mention the issue, and the Canadian Generic Pharmaceutical Association said it was disappointed no new resources at Health Canada were being directed to the problem, 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/].

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 more complex submissions can take longer [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of/].

Context for Canadian patients

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/]. Readers can follow remaining approval decisions on the generic semaglutide tracker, check the insurance coverage checker, or review the FAQ for additional product information including Wegovy, Mounjaro, and Zepbound.