Health Canada approves a second generic semaglutide injection, from Apotex
A second copy of the semaglutide injection is now cleared in Canada, a step toward cheaper versions of Ozempic there, with no word yet on the US market.
Health Canada granted authorization on May 1, 2026, to a second generic version of the semaglutide injection, this one from Apotex, a Canadian manufacturer [1]. The agency had cleared the first such product three days earlier, on April 28, 2026 [1].
The Apotex shot is a copy of Ozempic and carries the same labeled use: once-weekly treatment for adults with type 2 diabetes whose blood sugar needs managing [1]. Health Canada's release does not list obesity or weight management as an authorized indication, and the company has not said whether it will seek one [1].
Seven more applications for copies of the drug are pending at the regulator, filed by other companies, and decisions on some could arrive within weeks or months [1]. Health Canada describes itself as the first regulator among the Group of Seven nations to allow a generic semaglutide [1].
The BMJ reported that the country is only the second anywhere to approve a generic form of Ozempic, and linked the opening to Novo Nordisk's failure to pay a C$250 annual fee [2]. The two manufacturers it named were Dr Reddy's Laboratories of India and Apotex [2]. A Dr Reddy's version reached the Canadian market on May 15, 2026, while no launch date has been given for the Apotex product [2].
Erez Israeli, chief executive of Dr Reddy's, said the company remains "dedicated to expanding access to innovative, high-quality, affordable GLP-1 treatments for patients with diabetes" in the country [2].
Regulators describe these products as complex synthetic medicines that are pharmaceutically equivalent to the brand-name biologic, adding that their review checks whether any differences alter safety, effectiveness or quality [1]. Apotex's filing, according to Health Canada, was backed by evidence meeting the agency's standards for generics on those three fronts [1]. The regulator said it will keep watching the safety and performance of every generic semaglutide it has passed, and would intervene if problems surfaced [1].
Cost is the backdrop. Canadian generics often sell for 45% to 90% less than the brands they copy, according to the agency, whose turnaround target for generic files is shorter than that of many counterparts abroad [1].
Why it matters for patients
Canadians who inject semaglutide for type 2 diabetes now have a second approved supplier, which can matter for supply and for price over time. The 45% to 90% discount range the regulator cites applies to generic drugs generally in Canada, not specifically to this molecule [1].
The label here covers diabetes only. Whether a generic semaglutide is authorized or sold in Canada for weight loss has not been disclosed [1][2].
Nothing in either announcement concerns the United States. No generic semaglutide has been reported as cleared by the US Food and Drug Administration, and no timeline or pricing for a US launch has been made public [1][2].
What happens next
Health Canada has said it will rule on additional generic semaglutide files in the weeks and months ahead [1]. Dr Reddy's began selling its version in Canada on May 15, 2026 [2]; Apotex has not announced when its product will ship [2].
People who want to know which version they would receive, or what either one will cost at the pharmacy, will have to wait for those details to be published.
Sources
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