The arms race over the next generation of obesity drugs is continuing to heat up. This week, pharmaceutical company Eli Lilly announced it was suing several pharmacies, spas, and wellness centers in the U.S. for allegedly selling unauthorized copycats of its blockbuster drug tirzepatide, which is expected to be formally approved for treating obesity soon. The Food and Drug Administration has previously warned the public to stay away from sketchy sources of the similar drug semaglutide, sold under the brand names Ozempic and Wegovy.
Tirzepatide is the active ingredient in Eli Lilly’s injectable drug Mounjaro, which is currently approved for type 2 diabetes. It’s the latest in an emerging class of medicines that act as synthetic versions of hormones key to controlling our hunger and metabolism. Like semaglutide, tirzepatide mimics the hormone GLP-1, but it also mimics the hormone GIP. The combination is intended to boost its potency, a strategy that seems to have paid off. In large-scale clinical trials of tirzepatide for obesity, people have lost an average of 20% to 25% of their baseline weight, noticeably above the 15% or so average weight loss seen with semaglutide in similar trials (itself far above the success seen with past weight loss drugs). Both drugs have appeared to be generally safe, though they do commonly cause gastrointestinal symptoms that can be very intense for some people.
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With the release of its positive Phase III data this spring and summer, Eli Lilly is expected to win approval for tirzepatide as an obesity drug as early as late 2023. However, doctors have already been prescribing Mounjaro off-label to some of their patients. And some people have been desperate enough to seek out tirzepatide and semaglutide from less scrupulous places. Spas, wellness centers, and some doctors have relied on compounding pharmacies—pharmacies typically used to create custom-made medications for patients with special needs—to produce off-brand, usually cheaper versions of these drugs.
Earlier this May, the FDA announced that it had received adverse event reports from people using compounded semaglutide. The agency also warned the public to stay away from these unregulated medications, noting that some pharmacies may be using wholly unapproved formulations. Novo Nordisk, the makers of Wegovy and Ozempic, has already begun to sue specific companies for producing or selling compounded versions of their products. And now Eli Lilly has joined the fray.
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“Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product,” the company said in a statement released Tuesday. “Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro® (tirzepatide) by medical spas, wellness centers and compounding pharmacies.”
While some of the interest in black market semaglutide and tirzepatide might be fueled by customers otherwise not eligible for these drugs, there are other important factors. Both Eli Lilly and Novo Nordisk have faced supply shortages at various points, which has also impacted diabetes patients. In the U.S. specifically, both drugs are pricey and often not covered by insurance, costing upwards of $1,000 a month without coverage.
The future of weight loss treatment isn’t looking to get any less tangled anytime soon either. There are dozens of other potential obesity drugs coming down the pipeline, from Eli Lilly, Novo Nordisk, and many other competitors. Some of these treatments may be even more effective than tirzepatide, while others might provide more convenience, such as being available in a pill.
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