Health Canada has approved the first generic version of brand-name Ozempic.
The department says Canada is the first G7 country to authorize generic semaglutide.
The injectable medication is manufactured by Dr. Reddy’s Laboratories in India and is approved for the once-weekly treatment of Type 2 diabetes in adults.
In a news release, Health Canada says many generic medications are 45 to 90 per cent cheaper than brand-name versions.
Many people without drug coverage have been eagerly waiting for generic semaglutide because Novo Nordisk’s Ozempic can cost hundreds of dollars a month.
Although those medications are approved for diabetes treatment, they are often prescribed off-label for weight loss.
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Health Canada says it continues to review eight other generic semaglutide submissions from other companies.
How much cheaper generic semaglutide will be than Ozempic depends on how many generic options are approved and hit the market, said Mina Tadrous, a pharmaceutical policy expert at the University of Toronto.
According to the pricing structure of the pan-Canadian Pharmaceutical Alliance, the first generic medication could cost 75 to 85 per cent of the brand name. Once a second medication enters the market, the price for both drops to 50 per cent. When there are three or more generic products available in Canada, the cost would decrease to about 35 per cent of brand-name Ozempic’s price.
India’s drug agency approved two generic semaglutide medications by Dr. Reddy’s Laboratories in March, after Novo Nordisk’s Ozempic patent expired in that country.
The generic semaglutide approved by Health Canada on Tuesday was submitted for review in early 2024.
Health Canada said it met its target timeline of six months because it doesn’t include the time required for the company to provide additional data or information requested by the department.
“The generic versions of semaglutide are complex synthetic products that are pharmaceutically equivalent to the brand-name biologic drug. Health Canada’s review ensures that differences between these products do not affect the safety, efficacy or quality of the drug,” the department’s news release said.
“The availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the health-care system.”
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