Health Canada Notice: Eight More Generic Semaglutide Files in Queue

Health Canada's official April 28, 2026 announcement confirming Canada as the first G7 country to authorize a generic semaglutide injection also disclosed that eight other generic semaglutide submissions from different companies remain under review, with regulatory decisions expected 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].

What the Health Canada notice says

The Ottawa-issued notice, dated April 28, 2026, states that the first authorized generic semaglutide injection was the submission filed by Dr. Reddy's Laboratories, and that it is a generic version of 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 the approval followed a review of evidence demonstrating the drug meets its criteria for safety, efficacy and quality for generic drugs [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

The notice characterizes generic semaglutide as a complex synthetic product that is pharmaceutically equivalent to the brand-name biologic drug, and states the authorized product is indicated for once-weekly treatment of adult patients with type 2 diabetes to manage blood sugar levels [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

Eight other submissions still under review

According to the same notice, Health Canada is currently reviewing eight other submissions for generic semaglutide from different companies [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 it 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].

Subsequent reporting in The BMJ noted that a second generic version — from the Canadian company Apotex — was also approved by Health Canada in the weeks that followed, and that seven other applications remained under review at the time of publication [Source: bmj.com/content/393/bmj-2026-597166]. The BMJ further reported that the Dr. Reddy's product became available in Canada on May 15, 2026 [Source: bmj.com/content/393/bmj-2026-597166].

G7 first

Health Canada explicitly described the Dr. Reddy's authorization as the first generic semaglutide to be approved 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]. The BMJ characterized Canada as only the second country in the world to approve a generic form of semaglutide, a step it linked to Novo Nordisk not paying a C$250 annual fee [Source: bmj.com/content/393/bmj-2026-597166].

Market context

Global News reported that Apotex said its generic semaglutide will be approximately one-third the price of Novo Nordisk's brand-name Ozempic, while a spokesperson for Dr. Reddy's said pricing would be "competitive" without disclosing specifics [Source: globalnews.ca/news/11857122/generic-semaglutide-canada-sales-begin/]. Global News also reported that under the pricing structure of the pan-Canadian Pharmaceutical Alliance, when two generic medications enter the market they are at least 50 per cent cheaper than the brand name, though companies can price them lower [Source: globalnews.ca/news/11857122/generic-semaglutide-canada-sales-begin/].

Benefits and Pensions Monitor reported that once three generic competitors are on the market, Canadian policy will drive list-price discounts of about 65 percent [Source: benefitsandpensionsmonitor.com/benefits/pharma/ozempic-generics-set-to-test-canadas-drug-budgets/392976]. The same publication noted that Health Canada had nine generic semaglutide applications under review at the time of its January 2026 report [Source: benefitsandpensionsmonitor.com/benefits/pharma/ozempic-generics-set-to-test-canadas-drug-budgets/392976].

What it means for prices

Current pharmacy listings on GLP1Prices.ca show Ozempic ranging C$215–C$663, Wegovy ranging C$270–C$550, and Rybelsus ranging C$230–C$294 across our verified retail dataset. Tirzepatide products from Eli Lilly — Mounjaro and Zepbound — are not affected by the semaglutide approval pathway described in the Health Canada notice.

Monitoring

Health Canada said it will continue to monitor the safety and effectiveness of all generic semaglutide products, and will take appropriate action should unexpected safety or effectiveness concerns arise [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html]. Readers tracking pending decisions can follow our generic semaglutide tracker or check the insurance coverage checker and FAQ for guidance.

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