Health Canada has authorised the country's first generic version of semaglutide for weight loss, the department announced, marking the third generic semaglutide product cleared by the regulator this year and expanding access to a drug class that has surged in global demand.
Apotex Drug Cleared After Review
The approved product, branded Sevmia, was submitted by Canadian pharmaceutical firm Apotex as a generic equivalent of Wegovy, the brand-name weight-loss injection.
Health Canada said the authorisation followed a thorough review in which Apotex demonstrated the drug met the regulator's safety, efficacy and quality standards for generics. The injection is approved for once-weekly use in patients aged 12 and above, to be used alongside a reduced-calorie diet and increased physical activity for chronic weight management.
Health Canada said it is currently reviewing six other submissions for generic semaglutide from different companies and expects to issue further regulatory decisions in the coming weeks and months.
Third Approval This Year
The latest clearance follows two earlier milestones for Apotex. On April 28, Health Canada became the first regulator among G7 nations to approve a generic version of semaglutide.
Days later, on May 1, it cleared a separate Apotex submission for once-weekly treatment of adult type 2 diabetes patients to manage blood sugar levels. Monday's approval extends that progress to the weight-loss indication specifically.
ALSO READ: Abu Dhabi Proposes New Offshore-Oil Pricing After War Shock
Cost Savings Expected
Health Canada said generic semaglutide products are pharmaceutically equivalent to the original biologic drug, with its review process ensuring differences between the two do not affect safety, efficacy or quality.
The department noted that generic medications in Canada are typically priced 45 to 90% lower than their brand-name counterparts, raising the prospect of significant cost savings for patients and the wider healthcare system as more generics enter the market.
The regulator added that it would continue monitoring the safety and effectiveness of all generic semaglutide products following approval and would act if any unexpected concerns emerged.
Semaglutide-based drugs, including Novo Nordisk's Ozempic and Wegovy, have seen explosive global demand in recent years for both diabetes management and weight loss, prompting regulators worldwide to fast-track generic alternatives.
Essential Business Intelligence, Sharp Market Insights, Practical Personal Finance Advice, Daily Fuel, Gold and Silver Prices and Latest Stories — On NDTV Profit.