Health Canada Approves First Generic Versions of Diabetes Drug Ozempic

Health Canada approved the first generic version of Ozempic by Dr. Reddy's Laboratories on April 28 and later cleared a second generic version from Apotex. The health agency is reviewing seven other generic versions of Ozempic for approval.

The developments mark the arrival of the first generic versions of the diabetes drug in North America. S. Other generic versions of the drug have been available in India.

Semaglutide is the active ingredient in Ozempic and Wegovy. Those two new generics in Canada likely mark the start of a decline in international revenue of semaglutide, BMO Capital Markets analyst Evan Seigerman said in a note late last month. They will also be a test case for how well generics can compete against branded GLP-1 treatments, he added.

His firm will look at "how quickly pricing compression and revenue erosion impact Ozempic in the market as a proxy for other future generic entries," Seigerman said. Novo Nordisk sees a low single-digit impact of generics in Canada, Emil Kongshøj Larsen, the company's executive vice president of international operations, said on an earnings call this week.

Larsen added that the "leading tactic" in Canada is Novo's savings card, which has seen "very good uptake" for both Ozempic and Wegovy.

Canadian policy mandates a 65% price cut to Novo's list price once three generic competitors are on the market. " The company will watch for the entry of that third generic. Ozempic is a medicine for adults with type 2 diabetes that, along with diet and exercise, may improve blood sugar.

The approvals by Health Canada on April 28 and shortly afterward represent the first such generic entries for the drug in North America. Analysts will monitor how pricing and revenue respond as additional generics potentially reach the market.