Ozempic and its weight-loss formulation Wegovy lose their legal protections in January, opening the door for generic versions of semaglutide, the active ingredient in the drugs.George Frey/Reuters
Patients in Canada may have to wait longer to access generic versions of Ozempic because of continuing delays in processing of new drug submissions at Health Canada, according to Swiss generic drug manufacturer Sandoz.
Ozempic, the best-selling drug in Canada, and its weight-loss formulation Wegovy lose their legal protections in January, opening the door for generic versions of semaglutide, the active ingredient in the drugs.
Canada is the first major market in the world where generic semaglutide will be legal, and seven drug manufacturers have so far filed with Health Canada, the first in February, 2024.
At the same time, Health Canada has been dealing with a historic backlog of generic drug submissions. Although the department has a target of responding to all such submissions within 180 days, it hit that target only 84 per cent of the time in the fiscal year that ended March 31, according to data reported by The Globe and Mail. In most of those cases where the target was hit, the applications were rejected within days of the 180-day deadline and then accepted after further review.
Health Canada cannot give a full approval for a generic drug until market exclusivity ends – which for semaglutide is Jan. 4 – but generic drugmakers say progress so far is casting doubt on the notion that approvals will be ready then.
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Sandoz Canada Inc., a subsidiary of generics giant Sandoz Group AG, filed its application in November, 2024. A year later, the company is still answering questions from Health Canada about its submission.
Michel Robidoux, general manager of Sandoz Canada, said more Canadians will be able to access the drug and they will save money when the cheaper, generic version is available.
“So we are working very hard, but the road to get this drug approved is probably longer than expected.”
He said that, as far as they are aware, their competitors are in the same boat and the industry is not expecting generic semaglutide to have a major place in the Canadian market until mid-2026, though he cautioned that could change.
Semaglutide is a more complicated pharmaceutical product than other generic submissions. It mimics the GLP-1 gut hormone to slow digestion and reduce appetite.
Mr. Robidoux acknowledged that chemical complexity is adding to regulatory complications for the synthesized versions of semaglutide that Sandoz and other companies are proposing. Health Canada has requested more data than it would on a more standard generic submission.
But he pointed to Brazil, where Ozempic’s patent runs out in March. Three months ago, Brazil’s health regulator proactively notified drugmakers – including Sandoz – that it would prioritize submissions for generic semaglutide because of the drug’s high uptake and to help ensure a consistent supply.
It is just as popular in Canada, where more than a million people currently take a semaglutide drug, according to Ozempic maker Novo Nordisk.
Indian pharmaceutical company Dr. Reddy’s Laboratories Ltd., which submitted to Health Canada in February or March last year, disclosed publicly recently that it had received a notice of non-compliance from Health Canada, which indicated the company still had further questions to answer about its submission.
Prime Minister Mark Carney’s election platform in April promised to speed up drug approvals in Canada, which have among the longest wait times in the developed world.
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Health Minister Marjorie Michel’s office said they are working on the issue and see the importance of cutting red tape to get treatments to patients sooner and create a more attractive environment for businesses.
“The approval process currently takes too long, with bureaucracy getting in the way of delivering essential medications to Canadians who need them,” spokesperson Guillaume Bertrand said.
Health Canada did not respond specifically to a question about semaglutide submissions, but said generally the department is working to modernize drug-approval regulations and more complex submissions can take longer.
Despite the campaign promise, the federal budget tabled this month did not mention the issue. The Canadian Generic Pharmaceutical Association said it was disappointed no new resources at Health Canada were being directed to the problem, especially as most of the work is paid for by industry fees. The group said more than 500 generic submissions were under review, of which more than 100 were backlogged.
“Every day of delay in approving these medicines costs the health care system millions and denies drug plans the savings needed to fund new treatments, which is not in the interests of Canadian taxpayers, employers, and patients,” association president Jim Keon said in a statement earlier in November.