Health Canada Approves First Generic Semaglutide

Health Canada approved the first generic version of semaglutide, the active ingredient in Novo Nordisk's Ozempic, on April 28. The authorization went to Dr. Reddy's Laboratories, an India-based pharmaceutical company, marking the first such approval in a G7 nation.

The decision allows Dr. Reddy's generic injectable, which matches Ozempic dose-for-dose at 2 milligrams and 4 milligrams per weekly pen for adult type 2 diabetes patients, to enter the Canadian market. Health Canada confirmed the product is pharmaceutically equivalent to the brand-name version in safety, efficacy, and quality. Regulators assigned drug identification numbers and completed the review within their 180-day target.

Novo Nordisk's patents on semaglutide lapsed in Canada on January 4 after the company failed to pay an annual maintenance fee starting in 2019. Nine companies, including Dr. Reddy's, have filed for generic approvals, with eight submissions still under review. Health Canada expects decisions soon. "The availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the healthcare system," the agency stated.