Australia Bans Replica Versions Of Popular Weight-Loss Drugs From Novo Nordisk, Eli Lilly On Safety Concerns

Australia announced on Wednesday that it would ban compounded versions of weight-loss drugs like Novo Nordisk A/S’s NVO Ozempic and Eli Lilly And Co’s LLY Mounjaro, citing safety concerns.

Recently, the Chinese regulatory authority approved Eli Lilly’s diabetes drug, tirzepatide.

Health Minister Mark Butler emphasized that these unregulated copies have not undergone rigorous testing, leading to potential patient risks.

Demand for Ozempic and Mounjaro has surged due to their effectiveness in weight loss. However, the popularity of these medications has led to shortages, prompting some patients to turn to compounded alternatives.

Compounded drugs are custom-made versions based on the same ingredients as branded drugs. While often cheaper, they lack clinical evaluation by regulators for safety, quality, or efficacy. Butler noted a rise in reports of adverse events linked to these GLP-1 copies, including a serious incident that resulted in hospitalization.

Reuters noted that to protect public health, Butler announced new regulations to remove GLP-1 receptor agonists, such as those being misrepresented and sold as replicas of Ozempic or Mounjaro, from pharmacy compounding exemptions starting October 1.

This timeframe allows patients to transition to regulated drugs. Currently, around 20,000 Australians use pharmacy-made compounded versions of Ozempic and Mounjaro, primarily for weight loss, Reuters noted.

In February, FDA Commissioner Dr. Robert Califf expressed concerns about the online prevalence of compounded weight-loss drugs.

In April, U.S. District Judge Roy Altman ruled that Eli Lilly cannot rely on state law to stop a compounding pharmacy, RXCompoundStore.com, from marketing its version of the drug tirzepatide.

Price Action: NVO shares are down 0.76% at $134.14, and LLY stock is down 0.60% at $798.32 at last check Wednesday.

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LLYEli Lilly and Co

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