Seven Generic Semaglutide Files Remain Under Health Canada Review

Health Canada is reviewing seven additional generic semaglutide submissions from different companies following its authorization of products from Dr. Reddy's Laboratories and Apotex earlier this year, and expects to issue more regulatory decisions 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].

Two authorizations, seven files in the queue

Health Canada authorized the first generic semaglutide injection on April 28, 2026, a product filed by 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]. The department described the decision as the first generic semaglutide authorized in the G7 [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, Health Canada authorized a second generic semaglutide injection, filed by Canadian-based Apotex, also referencing Ozempic [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html]. At the time of the Apotex decision, Health Canada said seven other submissions from different companies remained under review [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Review timeline and queue size

The CBC reported that Health Canada said there were nine generic semaglutide medications under review for approval in Canada, and that the agency's target timeline for initial review of a generic drug is 180 days [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339]. The agency said it was "on track to meet review targets" for submissions for generic semaglutide medications [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339].

The BMJ reported that two generic versions of the injectable form of semaglutide had been approved by Health Canada in recent weeks, from India's Dr Reddy's Laboratories and the 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 May 15, while the Apotex version did not yet have a release date at the time of publication [Source: bmj.com/content/393/bmj-2026-597166].

Indications and scope

Both authorized generic semaglutide injections 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]. Health Canada described the generic versions of semaglutide as complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

The department said the availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the healthcare system [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html]. Health Canada said it will continue to monitor the safety and effectiveness of all generic semaglutide products [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

Company statement

Erez Israeli, chief executive of Dr Reddy's, said in a press release: "As the first company to receive market authorisation for generic semaglutide injection in Canada, we remain dedicated to expanding access to innovative, high-quality, affordable GLP-1 [glucagon-like peptide-1] treatments for patients with diabetes in the country" [Source: bmj.com/content/393/bmj-2026-597166].

Pricing context

The CBC reported that Mina Tadrous, associate professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto, estimated that once enough generics come online, prices could be around $100 a month or less depending on the dosage [Source: cbc.ca/news/health/generic-ozempic-canada-waiting-9.7142339]. Current pharmacy prices listed on GLP1Prices.ca for Ozempic range from $215 to $663 CAD across 83 verified pharmacy entries, while Wegovy ranges from $300 to $550 CAD. Brand-name Mounjaro and Zepbound products from Eli Lilly remain outside the semaglutide generic pathway and are tracked separately.

Readers tracking incoming approvals can follow our generic semaglutide tracker, check plan rules through our insurance coverage checker, or review our FAQ for general background on Canadian GLP-1 regulation.

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