GP concern over new Ozempic copycat

A replica of the TikTok-famous injectable semaglutide (sold as Ozempic) is about to hit the Australian market, despite stark warnings from the country’s medicine regulator.
 
Woolworths-backed telehealth start-up Eucalyptus has announced it is working with pharmacies to sell the copycat, which contains the same active ingredient as the Novo Nordisk-produced GLP-1 RA.
 
Eucalyptus’ compounding partners will use semaglutide sodium, a ‘powder-based raw ingredient’.
 
The decision comes as demand for the diabetes drug continues to skyrocket after it reached social media fame for its weight loss success.
 
But thanks in-part to that off-label prescribing, as well as the Novo Nordisk’s prioritisation of its weight-loss medication Wegovy, which uses the same active ingredient, the world is suffering a severe shortage of semaglutide expected to last well into next year.
 
Eucalyptus is aiming to fill that gap with its replica, which will be prescribed by its doctors and delivered to patients.
 
Currently, Novo Nordisk is the only pharmaceutical company with Therapeutic Goods Administration (TGA) approved products that contain semaglutide.
 
However, the TGA has said it is aware of rising numbers of telehealth providers offering compounded semaglutide-like products.
 
‘Compounded semaglutide-like products are “unapproved” therapeutic goods and have not been evaluated by us for safety, quality, and efficacy,’ it said.
 
‘The compounding of medicines should be reserved for exceptional clinical circumstances where all suitable alternative treatments using approved therapeutic goods, which are those included on the Australian Register of Therapeutic Goods [ARTG], are unavailable, have failed or are deemed unsuitable for the patient.’ 
 
The plan comes after Eucalyptus began prescribing semaglutide for weight loss earlier this year, despite a TGA request to avoid ‘off-label’ use.
 
Eucalyptus Clinical Director Dr Matthew Vickers has also spoken out to allay concerns, telling newsGP the organisation is taking extra steps to ensure the most rigorous safety standards are followed.
 
‘Based on the tests completed, the independent experts found that it was safe … in addition, every single batch of compounded semaglutide will undergo sterility testing for safety,’ he said.
 
‘Practitioners have so far only approved compounded semaglutide produced by two selected pharmacies, based on their safety and quality track record.
 
‘By utilising safe and high-quality compounding pharmacies our practitioners can maintain continuity of care for our patients.’
 
However, RACGP Specific Interests – Diabetes Chair Dr Gary Deed remains deeply concerned about the risks associated with the use of injectable compounded semaglutide.
 
‘You just need to ask yourself some simple questions,’ he told newsGP.
 
‘Am I fully comfortable with prescribing an injectable medication outside of TGA regulations and taking full medico-legal responsibility for offering this to my patients?
 
‘I did not see any response to how these additional risk factors are being managed, as TGA-approved products undergo such rigorous assessments.
 
‘I hesitate to state it is dangerous, but could it be unwise and ill-informed on an individual basis – possibly?’
 
Dr Vickers said Eucalyptus has received customer feedback that the lack of certainty on medication supply concerns them, and that the company is ‘following the lead of hundreds of medical practitioners across the country and making the decision to offer compounded semaglutide to their patients’.
 
‘Compounding happens every day in Australia – for medications such as antibiotics, dermatological, paediatric and hormonal treatments and common medications not readily available within Australia,’ he said.
 
But moving forward, Dr Deed said GPs should provide support for weight management which only includes viable TGA registered alternatives.
 
‘There has been an issue with compounding for many years. The majority of compounding, however, relates to oral and topical forms of medications,’ he said.
 
‘When we are stepping up to injectables, there is not just an onus on authenticating the chemical compound … but infection control, stability of the substance, expiry certification and safe injectable techniques need to be added to the quality assurance processes.’
 
RACGP President Dr Nicole Higgins has also raised safety concerns and referenced a recent warning from the US Food and Drug Administration about the fact that salt-based semaglutide has not yet been found to be safe or effective by a regulator.
 
‘What are the quality controls?’ she asked.
 
‘What are the guarantees? What are the potential impacts, side effects, [and] complications to the person who’s taking the medication?’
 
Eucalyptus has indicated to customers that the first doses of compounded semaglutide will become available in the coming weeks.
 
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