Companies can make generic Ozempic as of next week, but don’t expect to get it soon


TORONTO — Drug companies in Canada are allowed to make lower priced generic versions of the blockbuster drug Ozempic as of next week, but experts say patients shouldn’t expect it to be available for at least a few months.

As of Dec. 29, Health Canada had received nine submissions seeking approval to make semaglutide, the active ingredient in Ozempic and Wegovy, the brand-name diabetes and weight-loss drugs manufactured by Novo Nordisk.

“Health Canada understands that there is considerable interest in lowering costs associated with this highly prescribed drug by introducing generic versions,” spokesperson Mark Johnson said in an email to The Canadian Press.

Sandoz Canada, Apotex, Teva Canada, Taro Pharmaceuticals and Aspen Pharmacare Canada have all applied for Health Canada authorization, according to its list of generic submissions.

Sandoz Canada and Teva Canada told The Canadian Press they couldn’t provide any information on expected timelines for their products, while the others either could not be reached or did not respond to requests for comment.

The remaining companies weren’t named because their submissions were received prior to April 1, 2024, when the policy requiring a sponsor name changed, Johnson said.

Mina Tadrous, a pharmaceutical policy expert at the University of Toronto, said a generic semaglutide medication is unlikely to be approved until late spring or early summer.

“Canadians should not be expecting a product in January,” he said.

Based on generic pricing models in Canada, patients can expect the drug to be priced as low as 35 per cent of the brand-name Ozempic cost, which can be a few hundred dollars a month, Tadrous said, noting that there will likely be multiple generic semaglutide medications competing with each other.

The “target timeline” for Health Canada’s scientific review of generic drug submissions is 180 days, Johnson said.

That doesn’t include the extra time required if Health Canada needs more information from the drug company.

Evaluating generic semaglutide drugs is more complex than many other medication approvals, he said.

That’s because semaglutide was originally developed using biological processes, but the generic versions can be made using more simple chemical means .

“Generic semaglutide products are complex synthetic products that are pharmaceutically equivalent to the brand name drug, but with possible differences that could impact safety and efficacy,” Johnson said.

“The manufacturer must show that these differences do not affect the safety, efficacy, or quality of the drug compared to the brand name drug.”



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