Health Canada approves generic Ozempic, a first for the G7

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Canada is the first G7 nation to allow a generic version of a semaglutide injection after a pharmaceutical equivalent of the popular Ozempic drug received regulatory approval.

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Health Canada announced its decision on Tuesday to approve the submission filed by the global pharmaceutical company Dr. Reddy’s Laboratories, which is based out of Hyderabad, India, and operates a U.S. headquarters in New Jersey.

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They said eight other generic versions of the drug are in the queue to be approved by regulators and that the “complex” synthetic products 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 department’s news bulletin said. “The availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the health-care 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.”

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The drug is used for the weekly treatment of Type 2 diabetes in adult patients who need to manage their blood-sugar levels, according to Health Canada, which added that “many” generic drugs are about 45% to 90% cheaper than brand-name versions.

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By comparison, a prescription for Novo Nordisk’s Ozempic brand – which has gained attention for being prescribed as an off-label method to help with weight loss – can cost Canadians hundreds of dollars a month, according to The Canadian Press.

The cost of generic versions will depend on how many are approved and end up on the market with the pan-Canadian Pharmaceutical Alliance pricing structure listing a single-source product potentially costing about 75% to 85% of the price of the brand-name product.

Dual-source products can be priced at 50% of the cost of a brand-name medication, while multi-source products drop to 25% to 35% of the brand-name cost.

India gave the OK to two generic semaglutide drugs made by Dr. Reddy’s Laboratories in March after Ozempic’s patent expired there, according to The Canadian Press. That was after they submitted their product for review in Canada in 2024.

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