FDA says knockoff versions of Lilly obesity drug must come off the market

[December 20, 2024]  By MATTHEW PERRONE

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.

With demand for GLP-1 drugs booming, compounding pharmacies and telehealth companies like Hims and Ro have jumped into the market, selling cheaper versions online. People can usually get a month's supply for several hundred dollars.

A sign for Eli Lilly & Co. stands outside their corporate headquarters in Indianapolis on April 26, 2017. (AP Photo/Darron Cummings, File)

Thursday’s decision gives businesses between 60 and 90 days, depending on their size, to phase out their products.

The FDA permits compounded versions of brand name drugs when they are in shortage, and the shift back to Lilly’s medications could improve safety for consumers. The FDA warned patients last year about problems with the ingredients and formulations of some GLP-1 drugs sold online. The agency has limited oversight of compounding pharmacies, which are primarily overseen by state authorities.

Compounding pharmacies use raw drug ingredients to produce customized versions of prescription medications — for instance, when patients have allergies to certain ingredients. The industry has grown into a multibillion-dollar business over the past decade amid increasing drug shortages.

Demand for off-brand GLP-1 drugs has been amplified by aggressive online promotions from telehealth companies, which aren’t subject to the same marketing rules as drugmakers.

The FDA previously declared an end to the shortage of Mounjaro and Zepbound in early October, but reversed its decision after public pushback and a lawsuit filed by compounding pharmacies.

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