Apotex Wins Health Canada Nod for 2nd Generic Semaglutide

Health Canada authorized a second generic semaglutide injection on May 1, 2026, this one filed by Canadian-based Apotex, with seven additional generic submissions still under review [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

What was approved

The Apotex submission is a generic version of the brand-name drug Ozempic and is 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 stated the drug was authorized after a thorough review of evidence demonstrating it meets the agency's criteria for safety, efficacy and quality for generic drugs [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

The second G7 first

The Apotex authorization follows Health Canada's April 28, 2026 approval of the first generic semaglutide injection, filed by Dr. Reddy's Laboratories, which made Canada the first G7 country to authorize a generic version of the molecule [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. The Dr. Reddy's product is manufactured in India and is also approved for the once-weekly treatment of type 2 diabetes in adults [Source: globalnews.ca/news/11826332/canada-approves-2nd-generic-version-semaglutide/].

Seven more submissions in queue

Health Canada confirmed that seven other submissions for generic semaglutide from different companies remain under review and that the department expects to make regulatory decisions on more of them 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]. That figure dropped from the eight other submissions cited at the time of the Dr. Reddy's authorization [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

Pricing context

Health Canada has stated that many generic medications are 45 to 90 per cent cheaper than the brand-name versions [Source: globalnews.ca/news/11826332/canada-approves-2nd-generic-version-semaglutide/]. Global News reported that, according to Felix, the average cost of Ozempic injections can be between $200 and $450 per month depending on each Canadian province [Source: globalnews.ca/news/11826332/canada-approves-2nd-generic-version-semaglutide/]. That range aligns with current pharmacy listings on GLP1Prices.ca, where Ozempic is tracked between CAD $200 and $663 per month across 149 pharmacy data points.

Global News also reported that Mounjaro ranges between $300 and $550 per month in Canada, and that Wegovy's current list price is expected to cost $5,066 per patient per year, or roughly $400 per month [Source: globalnews.ca/news/11826332/canada-approves-2nd-generic-version-semaglutide/]. Both ranges sit within the Mounjaro ($283.08–$813) and Wegovy ($270–$550) windows currently tracked on GLP1Prices.ca.

Coverage questions remain

Obesity Canada noted that fewer than 20 per cent of Canadians with private drug benefit plans have access to Health Canada-approved obesity treatment medications, and called on governments, insurers, and employers to revisit how obesity care is covered as lower-cost approved options become available [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/]. The organization said it does not endorse specific medications, brands, or manufacturers [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval/].

What it means for tracking

• Two Health Canada-authorized generic semaglutide injections are now on the books, both indexed to Ozempic's active ingredient [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].
• Seven additional submissions remain under Health Canada review [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].
• No generic versions of tirzepatide products such as Mounjaro or Zepbound have been authorized; only semaglutide generics are covered by these decisions.

Readers tracking pricing changes can monitor our generic semaglutide tracker and check our insurance coverage checker for province-by-province updates as plans respond to additional approvals.

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