Apotex Becomes Second Generic Semaglutide Cleared by Health Canada

Health Canada has authorized a second generic semaglutide injection, filed by Canadian-based Apotex, cementing Canada's position as the first G7 country to clear generic versions of the Novo Nordisk molecule sold under the Ozempic brand.

The second authorization

The Apotex submission is a generic version of the brand-name Ozempic injection. Health Canada stated that it cleared the product after a review of evidence demonstrating that the drug meets the regulator's criteria for safety, efficacy and quality for generic drugs. Apotex is described by Health Canada as a Canadian-based global pharmaceutical company specializing in producing and distributing generic drugs.

Following Dr. Reddy's

The Apotex clearance follows the first Health Canada authorization for a generic semaglutide injection, which went to Dr. Reddy's Laboratories. Health Canada noted that it completed the review of the Dr. Reddy's submission within its 180-day target timeline, though time spent by the manufacturer providing required or missing data does not count toward that target. On April 28, 2026, Health Canada announced it had become the first G7 country to approve a generic version of semaglutide.

Seven more submissions in the queue

Health Canada said it is currently reviewing seven other submissions for generic semaglutide filed by different companies, and expects to make regulatory decisions on more of these submissions in the coming weeks and months. The Generic Submissions Under Review list maintained by Health Canada tracks each pending file by medicinal ingredient, sponsor, and month accepted into review.

Backlog context

The additional clearances arrive against a backdrop of processing delays. In the fiscal year that ended March 31, Health Canada hit its 180-day response target for generic submissions only 84 per cent of the time. The Canadian Generic Pharmaceutical Association has said more than 500 generic submissions were under review, of which more than 100 were backlogged. Michel Robidoux, general manager of Sandoz Canada, told The Globe and Mail that the industry is not expecting generic semaglutide to have a major place in the Canadian market until mid-2026.

Pricing implications

Health Canada stated that many generic medications in Canada are 45 to 90 per cent cheaper than the brand-name versions. Current pharmacy prices tracked on GLP1Prices.ca for brand-name Ozempic range from CAD $93.29 to $663, while Wegovy ranges from $270 to $550 and Rybelsus ranges from $230 to $293.99. Tirzepatide products Mounjaro and Zepbound are not affected by the semaglutide filings.

What to watch

Health Canada has said it will continue to monitor the safety and effectiveness of all generic semaglutide products, and will take appropriate action if unexpected concerns arise. Readers tracking upcoming clearances can consult our generic semaglutide tracker, check plan reimbursement via the insurance coverage checker, or review common questions on the FAQ.

• First authorization: Dr. Reddy's Laboratories generic semaglutide injection
• Second authorization: Apotex generic semaglutide injection
• Still under review: seven other generic semaglutide submissions

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

Sources

• Canada approves second generic semaglutide, the first G7 ...
• Health Canada authorizes Dr. Reddy's generic Ozempic
• Generic submissions under review
• Health Canada approval backlog expected to push back ...