Australia to ban replicas of weight loss drugs Ozempic and Mounjaro

Australia will ban replicas of blockbuster weight loss drugs such as Ozempic and Mounjaro in a move set to slash their availability and disrupt the businesses capitalising on ballooning demand.

Health Minister Mark Butler’s decision will limit access for at least 20,000 Australians who have been buying compounded weight loss injections – meaning a pharmacist or healthcare practitioner has made the medicine themselves – because they cannot get the branded products during massive global supply shortages.

There has been overwhelming demand for Ozempic because of its weight-loss effects.Credit: Monique Westermann

While pharmacists are allowed to compound medicine on a case-by-case basis for people with prescriptions, it is not supposed to happen at a commercial scale because their products have not been tested for safety or quality by the Therapeutic Goods Administration.

But with global demand for the popular weight loss drugs far exceeding supply, Australian vendors have been mass-producing replica versions of Ozempic and Mounjaro, known as GLP-1 receptor agonists, despite the regulator’s warnings.

The medicines are regular injections that reduce a user’s appetite by mimicking hormones that cause the body to feel full.

Butler revealed the new regulations would remove GLP-1 receptor agonists from an exemption list that allows pharmacies to compound them, starting from October. Civil and criminal penalties under the Therapeutic Goods Act may apply to anyone who breaches them.

“I’m really concerned in the way in which this market has developed that compromises public safety,” he said.

“We recognise there is a valid place for compounding in certain circumstances. This action will not affect compounded medicines other than GLP-1 receptors. While I understand that this action may concern some people, the risk of not acting is far greater.

“You only have to look to the recent reports of individuals impacted by large-scale compounding to realise the dangers posed. This action will protect Australians from harm and save lives.”

Compounding has become a big business for online telehealth start-ups, such as the Woolworths-backed Eucalyptus and NIB’s Midnight Health, which use digital doctors’ consults to prescribe the drugs.

The practice has been resisted by the manufacturers – multibillion-dollar international pharmaceutical giants Novo Nordisk and Eli Lilly – whose profits have soared in the past two years.

Ozempic and Mounjaro were designed for diabetes but company trials soon showed patients lost up to 15 per cent of their body weight, leading share prices to skyrocket and sparking headlines about them revolutionising the future of obesity.

Ozempic is subsidised at $31.60 in Australia for type 2 diabetes but is frequently purchased “off-label” – meaning a purpose for which the drug has not been approved – for weight loss at a higher price, starting from $130 a month depending on the dosage. Mounjaro hit Australian shelves last year but is not subsidised by the government. The TGA says shortages of both are expected to continue.

The much-hyped drugs come with side effects: the most common are nausea, diarrhoea, constipation and dehydration, although the US Food and Drug Administration is also probing the risk of more serious side effects including hair loss and suicidal ideation.

The federal government said stopping the large-scale manufacture of compounded injections had broad support from the health sector, including general practitioners, the Medical Board of Australia, Diabetes Australia, the Eating Disorders Alliance of Australia and state and territory health departments.

Companies compounding the drugs could not be contacted because the government’s decision was not public, but they have previously argued their actions help make important medicines available to Australians who would otherwise be worse off.

“Without the medication and without the ongoing lifestyle changes that we are trying to do for these patients, the overwhelming data says that those patients will put the weight back on,” Eucalyptus chief executive Tim Doyle has said.

“In the situation where they put their weight back on, all of the health risks that come with that increase in likelihood.”

But the Therapeutic Goods Administration’s chief medical adviser, Professor Robyn Langham, said banning compounded weight loss drugs was the right action.

“The TGA will work with key medical, pharmacy and consumer stakeholders to support patients and their practitioners to navigate the change, and where appropriate help with guidance in finding alternative and safe medicines,” she said.

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