Canada has become the first G7 country to approve a generic version of semaglutide injection, following regulatory authorization of a pharmaceutical equivalent to the widely used diabetes drug Ozempic.
Health Canada announced that it approved a submission from Dr. Reddy’s Laboratories, a global pharmaceutical company headquartered in Hyderabad, India, with U.S. operations in New Jersey. The agency noted that several other generic versions are currently under review and that these complex synthetic products are considered pharmaceutically equivalent to the brand-name biologic drug.
According to Health Canada, its review process ensures that any differences between generic and brand-name versions do not affect safety, effectiveness, or quality. The introduction of generic alternatives is expected to lower costs for patients and reduce expenses within the healthcare system. As with all approved drugs, the agency will continue monitoring the safety and performance of generic semaglutide products.
Semaglutide is used as a weekly treatment for adults with Type 2 diabetes to help control blood sugar levels. Health Canada also noted that many generic medications are typically 45% to 90% cheaper than their brand-name counterparts.
By comparison, the original Ozempic product, manufactured by Novo Nordisk, can cost patients hundreds of dollars per month in Canada. The final price of generic versions will depend on market competition. Under current pricing structures, single-source generics may cost about 75% to 85% of the brand-name price, dual-source products around 50%, and multi-source versions between 25% and 35%.
India previously approved two generic semaglutide drugs from Dr. Reddy’s Laboratories in March after the expiration of Ozempic’s patent there. The company had submitted its product for review in Canada in 2024.
