Novo Nordisk has taken its fight over weight-loss drugs to federal court, targeting telehealth company Hims & Hers over what it calls unauthorized copycats of Wegovy and Ozempic. In a lawsuit filed Monday, the Danish drugmaker asked a court to block Hims & Hers from selling compounded versions of its obesity and diabetes medications and to award damages, reports the Wall Street Journal. Novo Nordisk argues that the products marketed by Hims & Hers bypass the FDA's standard approval process and therefore have not undergone the agency's full safety and efficacy review. The case reflects broader tensions over a booming market for weight-loss drugs and cheaper alternatives.
"This is a complete sham, and it has been a sham since the shortage ended," Novo attorney John Kuckelman tells CNBC. "The fact is that their medicines are untested, and they're putting patients at risk." Hims & Hers has defended compounded drugs, saying Novo Nordisk's actions could harm patients who depend on those options. The telehealth firm had announced plans last week to sell a less expensive compounded version of Novo Nordisk's new Wegovy pill before backing away from that rollout over the weekend under regulatory and legal pressure.
The company still offers compounded injectables, which do not contain Novo Nordisk's FDA-approved semaglutide and are positioned as alternatives to Wegovy and Ozempic. The FDA commissioner has vowed to crack down on illegal copycats, and federal health officials have referred Hims & Hers to the Justice Department for a potential investigation under the Food, Drug, and Cosmetic Act. Compounding pharmacies are allowed to make versions of drugs when there are shortages or when a customized formulation is medically necessary. Novo Nordisk's products were removed from the FDA's shortage list early last year, but compounded versions have continued to be sold.
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