OTTAWA, ON, April 28, 2026 /CNW/ - Today, Health Canada authorized a generic semaglutide injection. This is the first generic semaglutide authorized by Health Canada, and the first to be approved in the G7. Health Canada is currently reviewing eight other submissions for generic semaglutide by different companies. The department expects to make regulatory decisions on more of these submissions in the coming weeks and months.
The semaglutide injection submission filed by Dr. Reddy's Laboratories is a generic version of the brand name drug Ozempic. Health Canada authorized the drug after a thorough review of evidence provided by the company, demonstrated that the drug meets Health Canada's criteria for safety, efficacy and quality for generic drugs. Like existing products, this semaglutide injection is indicated for the once-weekly treatment of adult patients with type 2 diabetes to manage blood sugar levels.
The generic versions of semaglutide are complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug. Health Canada's review ensures that differences between these products do not affect the safety, efficacy, or quality of the drug. The availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the healthcare system.
As it does with all drugs authorized in Canada, Health Canada will continue to monitor the safety and effectiveness of all generic semaglutide products. Should any unexpected safety or effectiveness concerns arise, Health Canada will take appropriate action to protect the health and safety of Canadians.
Quick facts
- Health Canada completed the review of Dr. Reddy's submission within its target timeline of 180 days. The time the manufacturer takes to provide the required or missing data does not count toward the 180-day target, and once this information is received, a second round of review begins, extending the total time for the review.
- Health Canada's review target for generic drug submissions is shorter than many international regulators.
- In Canada, many generic medication are 45 to 90% cheaper than the brand name versions.
SOURCE Health Canada (HC)
