US Judge Bars Copies of Lilly Weight-Loss Drug
A U.S. federal judge has refused to allow compounding pharmacies to keep making copies of Eli Lilly's popular weight-loss and diabetes drugs Zepbound and Mounjaro in the United States. The decision was filed late on Wednesday in response to an October lawsuit from a compounding industry group against the U.S. Food and Drug Administration's decision last year that there was no longer a shortage of the medicines' active ingredient, tirzepatide. Compounders had been allowed to produce hundreds of thousands of doses of copies of obesity drugs only while the FDA said there was a shortage of them.
- The implications of this ruling on patient access to affordable weight-loss medications could be severe, particularly for those who rely on compounded versions due to high costs of commercial alternatives.
- Will regulators and pharmaceutical companies adapt their strategies to address rising demand for generic and biosimilar versions of Lilly's drugs in light of the FDA's revised stance on tirzepatide?