The Food and Drug Administration (FDA) has announced that it will phase out off-brand copies of two blockbuster drugs used to treat obesity and diabetes, Zepbound and Mounjaro. The decision comes after a nationwide shortage was resolved, making the need for copycat versions obsolete. Specialty pharmacies and online companies selling these cheaper alternatives must now discontinue their products within 60-90 days.
The move is a win for Eli Lilly, which had been pressing the FDA to take action for months. This change will impact how patients access these drugs, including their cost. Both Zepbound and Mounjaro are part of the GLP-1 class, which has shown remarkable results in helping people shed weight by reducing appetite and increasing feelings of fullness.
The FDA previously lifted its ban on compounded versions of brand-name drugs during shortages but reversed it after public pushback and a lawsuit from compounding pharmacies. This decision aims to improve safety for consumers, as the agency warned patients last year about problems with online GLP-1 drug ingredients and formulations. The industry has grown into a multibillion-dollar business over the past decade amid increasing drug shortages.
Demand for off-brand GLP-1 drugs was amplified by aggressive marketing from telehealth companies, which are not subject to the same regulations as pharmaceutical manufacturers. The FDA will now give businesses until 60-90 days to phase out their products, aiming to limit access to potentially inferior medications and ensure patients receive high-quality treatments.
Source: https://abcnews.go.com/Health/wireStory/fda-knockoff-versions-lilly-obesity-drug-off-market-116959863