Australia to ban knock-offs of popular weight-loss drugs Ozempic, Mounjaro

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Australia said on Wednesday it will ban copies of drugs used for weight loss such as Ozempic and Mounjaro, arguing that so-called compounded versions are not rigorously tested and are potentially unsafe.

Demand for Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro has soared due to the diabetes drugs being used for their weight-loss effects. They belong to a growing class of drugs called GLP-1 receptor agonists that reduces food craving and slows digestion, helping patients feel sated for longer.

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But their popularity has led to shortages, turning patients to compounded alternatives.

Compounded drugs are custom-made medicines based on the same ingredients as branded versions. They are often cheaper but are not clinically evaluated by regulators for safety, quality or efficacy.

Health Minister Mark Butler said there were increasing reports of patients coming to harm from GLP-1 copies, including the hospitalisation of an Australian due to a serious adverse event.

“To keep Australians safe, new regulations will remove (GLP-1 receptor agonists), such as those being misrepresented and sold as replica Ozempic or Mounjaro, from the pharmacy compounding exemptions,” Butler said in a statement.

The change will be effective from Oct. 1, giving patients time to source a regulated drug, he said.

At least 20,000 Australians are taking pharmacy-made compounded versions of Ozempic and Mounjaro, with the majority using them to shed weight, Butler said.

In February, US Food and Drug Administration Commissioner Dr. Robert Califf said he was concerned about the prevalence online of compounded versions of drugs used to lose weight.

Some analysts forecast the market for diabetes cum weight-loss drugs, currently led by Novo Nordisk and Eli Lilly, could reach $100 billion a year by the end of the decade.

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