No reason for patients to gamble with their health, warns firm
Novo Nordisk has filed a lawsuit against telehealth company Hims & Hers, accusing it of infringing a key US patent and putting patients at risk by selling unapproved versions of its blockbuster weight-loss and diabetes drugs Wegovy and Ozempic, according to a release Monday.
Additionally, Novo Nordisk claims Hims has run aggressive promotional campaigns for its compounded semaglutide offerings that mislead both consumers and healthcare professionals about the safety and clinical benefits of these products.
The firm highlights Hims’ recent launch – and two days later, abrupt discontinuation – of a “Compounded GLP-1 Pill,” which followed shortly after Novo Nordisk introduced its own Wegovy pill, described as the first and only FDA-approved GLP-1 pill for weight loss.
While the pill was pulled, Novo Nordisk says Hims continues to mass compound injectable versions of semaglutide using inauthentic active pharmaceutical ingredients, characterizing them as unsafe “knock-offs” that endanger patient health.
“Throughout Novo Nordisk’s 103-year-long history, patient safety has always been our top priority,” said John F. Kuckelman, senior vice president, group general counsel, global legal, IP and security at Novo Nordisk. He accused Hims & Hers of “mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process,” calling the practice dangerous, deceptive, and damaging to scientific and regulatory safeguards designed to ensure medicines “are safe and effective.”
Novo Nordisk says testing of pharmacy-compounded semaglutide has revealed alarmingly high impurity levels: up to 86 per cent in injectable products and up to 75 per cent in oral versions. Such contamination or incorrect dosing, it warns, can trigger serious and potentially life-threatening outcomes, including immune reactions, hospitalization, severe drug interactions and overdoses.
The company’s concerns are echoed by regulators and medical groups. According to the release, the FDA recently stated that mass-marketed compounded GLP-1 drugs are products for which it cannot verify quality, safety or efficacy. Organizations such as the American Medical Association, the American Diabetes Association and the Endocrine Society have similarly cautioned against using knock-off GLP-1 medicines, with the ADA advising against them given uncertainty about their content and effectiveness.
Novo Nordisk is asking the court to permanently bar Hims from selling unapproved, compounded semaglutide products it says infringe its patents and is seeking damages.
“With the supply of all doses of these medicines fully available nationwide in the US, there is no reason for patients to gamble with their health with knock-off products,” Novo said in a statement.
