Generic Semaglutide Pipeline: 7 Submissions Still Under Review

Health Canada says it is currently reviewing seven additional generic semaglutide submissions following the May 1, 2026 authorization of a second generic version of the molecule that powers Ozempic [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

The updated pipeline

In its May 1, 2026 announcement, Health Canada confirmed it had authorized a second generic semaglutide injection, filed by Canadian-based Apotex, and that seven other generic semaglutide submissions from different companies remain under review [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 expects to make regulatory decisions on more of those 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].

That figure represents a one-submission decrease from the eight files Health Canada had cited just three days earlier. On April 28, 2026, when the regulator authorized the first generic semaglutide injection — filed by Dr. Reddy's Laboratories and making Canada the first G7 country to approve a generic version of the molecule — the department said eight other submissions were under review [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide.html].

What Health Canada has authorized

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 describes the products as “complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug,” with the regulator’s review ensuring differences do not affect safety, efficacy or quality [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 added that it will continue to monitor the safety and effectiveness of all generic semaglutide products and take action if unexpected concerns arise [Source: canada.ca/en/health-canada/news/2026/05/canada-approves-second-generic-semaglutide-the-first-g7-country-to-do-so.html].

Who else is in the queue

Reuters reported that Swiss generic drugmaker Sandoz plans to launch a generic version of Ozempic in Canada by June 2026, positioning itself among the first wave of companies seeking to market copycat versions [Source: reuters.com/legal/litigation/health-canada-approves-first-generic-version-novo-nordisks-ozempic-2026-04-28/]. BMO Capital Markets analyst Evan Seigerman told Reuters that “Investors will follow the evolution of the market in Canada closely as a test case to see if and how generics can compete with branded peptides” [Source: reuters.com/legal/litigation/health-canada-approves-first-generic-version-novo-nordisks-ozempic-2026-04-28/].

Pricing context

Health Canada has stated that many generic medications are 45 to 90 per cent cheaper than brand-name versions [Source: reuters.com/legal/litigation/health-canada-approves-first-generic-version-novo-nordisks-ozempic-2026-04-28/]. Under the pan-Canadian Pharmaceutical Alliance generic drug framework, the first generic version of a medication typically costs 75 to 85 per cent of the brand price; with a second generic on the market the price typically drops to 50 per cent of the brand; and with three or more generics, prices typically decrease to about 35 per cent of the brand-name price [Source: globalnews.ca/news/11820779/canada-approves-1st-generic-ozempic-market/].

Global News, citing Felix, reported the average cost of Ozempic injections can be between $200 and $450 per month depending on the province, with Mounjaro ranging between $300 and $550 per month in Canada [Source: globalnews.ca/news/11820779/canada-approves-1st-generic-ozempic-market/]. Current pharmacy prices listed on GLP1Prices.ca run from $222 to $663 for Ozempic and $283.08 to $813 for Mounjaro, reflecting a wider range than the Felix figures cited above. Wegovy’s list price is expected to cost about $5,066 per patient per year, or roughly $400 per month [Source: globalnews.ca/news/11820779/canada-approves-1st-generic-ozempic-market/]; current Wegovy pharmacy prices on GLP1Prices.ca range from $270 to $550.

Coverage uncertainty

Whether provincial drug plans will reimburse generic semaglutide remains unsettled. Dr. Hertzel Gerstein, a professor in the medicine department at McMaster University, told Global News that approval at the federal level does not guarantee reimbursement and that each provincial Ministry of Health makes its own decision on inclusion in drug benefit programs [Source: globalnews.ca/news/11820779/canada-approves-1st-generic-ozempic-market/]. Patients can monitor product additions through the generic semaglutide tracker and check plan status using the insurance coverage checker, with additional background available on the FAQ.

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