Drug clones sought in shortage
Ozempic copycats are being targeted amid supply shortages.
In an unprecedented move, Novo Nordisk, the pharmaceutical giant behind the weight loss medication Ozempic, has urged Australian regulators to intervene against the production of copycat versions of the drug, citing public safety concerns.
The Danish company, valued at $600 billion and renowned for its contributions to diabetes treatment, has found itself at the centre of a healthcare debate due to the scarcity of Ozempic, a situation exacerbated by the drug's off-label use for weight loss.
Last year, Novo Nordisk reached out to the Pharmacy Board of Australia, expressing alarm over pharmacists' creation of compounded semaglutide, an alternative based on Ozempic's active ingredient.
In a detailed letter to Kym Ayscouch, the regulatory operations director for the Australian Health Practitioner Regulation Agency, Cem Ozenc, Novo Nordisk’s general manager for Oceania, has reportedly highlighted the potential hazards associated with such practices. “Compounding of sterile injectable medicines poses significant risks to the public if requirements are not strictly adhered to throughout the compounding and supply process,” Ozenc warned.
The company says compounded semaglutide should be restricted to a 24-hour expiry limit, contrary to the month-long duration offered by many pharmacies.
The request is driven by Ozempic's skyrocketing popularity for weight management, despite its official registration in Australia solely for diabetes treatment.
The shortage of Ozempic has led to the emergence of companies like Eucalyptus, which have been dispensing similar versions since December.
To fortify its position, Novo Nordisk has enlisted the services of Shawview Consulting and joined forces with Medicines Australia, signalling its readiness to protect its interests through lobbying and legal channels.
In the United States, Novo Nordisk has taken legal action against pharmacies accused of selling impure semaglutide.
The Pharmacy Board, while acknowledging Novo Nordisk's concerns, has remained neutral, emphasising its role in providing broad guidelines rather than dictating the production of specific medicines.
“Generally, when compounding medicines, pharmacists must ensure that there is good clinical and pharmaceutical evidence to support the quality, stability, safety, efficacy, and rationality of any extemporaneous formulation,” a board spokesperson has told reporters.