FDA wants knockoff versions of Lilly obesity drug to be stopped

WASHINGTON, D.C.: The Food and Drug Administration (FDA) has ordered specialty pharmacies and online companies to phase out knockoff versions of Eli Lilly's blockbuster drugs Zepbound and Mounjaro, following the resolution of a nationwide shortage.

In a decision announced this week, the FDA stated that Lilly's supply of obesity and diabetes medications now meets or exceeds demand, eliminating the need for copycat versions.

"This decision is a win for Lilly," which had urged the FDA to act for months, and is expected to impact patient access and costs. Zepbound, approved to treat obesity, and Mounjaro, approved for diabetes, share the active ingredient tirzepatide, which has gained widespread popularity for its weight-loss benefits.

The drugs belong to the GLP-1 class, which has shown remarkable results in helping patients lose weight by reducing appetite and enhancing feelings of fullness. Competing medications Wegovy and Ozempic, produced by Novo Nordisk, remain on the FDA's shortage list.

Compounding pharmacies and telehealth companies like Hims and Ro had stepped in during the shortage, offering cheaper off-brand versions online for several hundred dollars per month. The FDA's decision gives businesses 60 to 90 days to phase out these products.

While compounded versions of brand-name drugs are allowed during shortages, the FDA has warned of safety risks associated with some off-brand GLP-1 drugs sold online. The agency noted issues with ingredients and formulations last year and highlighted that it has limited oversight of compounding pharmacies, which are primarily regulated by states.

The compounded drug market has expanded significantly in recent years due to growing drug shortages. Compounding pharmacies create customized medications using raw drug ingredients, often for patients with specific needs like allergies.

Demand for off-brand GLP-1 drugs has also been fueled by aggressive online marketing from telehealth companies, which aren't subject to the same regulations as pharmaceutical manufacturers.

The FDA initially declared the shortage of Mounjaro and Zepbound over in October but reversed its decision after facing public backlash and a lawsuit from compounding pharmacies.

The latest decision signals a shift back to Lilly's original drugs, which could provide more consistent safety and quality for patients.