Canada has approved an Indian pharma company’s generic version of the anti-diabetes drug Ozempic, for use in the country.
Health Canada announced on Tuesday that the generic semaglutide injection from the Hyderabad-headquartered Dr Reddy’s Laboratories had been approved. Dr Reddy’s submission for approval was filed in January 2024.
The injection of the popular drug is used to control type 2 diabetes and has also been found effective as a weight loss agent.
In a release, Health Canada said not only was this approval the first for the country, it was “the first to be approved in the G7.”
Health Canada said it was currently reviewing eight other submissions from different companies.
The department said it authorized the drug “after a thorough review of evidence provided by the company, demonstrated” it met its “criteria for safety, efficacy and quality for generic drugs.”
It added as in the case of existing products, the Dr Reddy’s semaglutide injection was indicated for the once-weekly treatment of adult patients with type 2 diabetes to manage blood sugar levels.
It also said as it does with all drugs authorized in Canada, the department will “continue to monitor the safety and effectiveness of all generic semaglutide products.”
It pointed out that in Canada many generic medications are 45 to 90 per cent cheaper than the brand name drugs.
Health Canada said that the generic versions of semaglutide were complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug and its “review ensures that differences between these products do not affect the safety, efficacy, or quality of the drug.”
It said the availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the healthcare system.
Ozempic, made by the Danish healthcare company Novo Nordisk, was approved in Canada in January 2018 months after it was greenlit in the United States. It’s international patent for the blockbuster formulation expired in March this year.