FDA says knockoff versions of Lilly obesity drug must come off the market [View all]

Source: AP

Updated 6:26 PM EST, December 19, 2024


WASHINGTON (AP) — Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will need to phase out their versions next year under a federal decision issued Thursday.

The Food and Drug Administration said that a nationwide shortage of Eli Lilly’s Zepbound and Mounjaro has been resolved, eliminating the need for copycat versions of the drugs that have become wildly popular with Americans trying to lose weight.

The decision is a win for Lilly — which had been pressing the FDA to take the step for months — and is expected to impact how patients access the drugs, including how much they pay. Zepbound is FDA-approved to treat obesity and Mounjaro is approved for diabetes. They use the same active ingredient, tirzepatide.

The FDA said Thursday that “Lilly’s supply is currently meeting or exceeding demand,” after two years of shortages. Both drugs are part of the GLP-1 class that has shown unprecedented results for helping people shed weight by decreasing appetite and boosting feelings of fullness. Wegovy and Ozempic — competing drugs from Novo Nordisk — remain on the FDA’s shortage list.

Read more: https://apnews.com/article/obesity-drugs-zepbound-shortage-fda-13d18b0e3e74a7f7355521bf8e38cb5b