Novo Nordisk has taken legal action against the digital health platform Hims & Hers for allegedly “unlawfully” mass compounding “unsafe” and “knock-off” versions of its semaglutide weight loss drugs.
Filed on February 9, the lawsuit claimed that by “mass marketing unapproved versions” of Wegovy and Ozempic for the US market, the company is “deceiving patients and putting their health at risk”.
Read more: US pharmacy sues GLP-1 makers for ‘restricting competition’
Hims & Hers has “engaged in promotional campaigns that highlight its compounded semaglutide products”, Novo Nordisk said, claiming that this is “duping consumers and healthcare professionals as to the clinical benefits and safety” of the drugs.
Compounded semaglutide products “may contain dangerous impurities or incorrect amounts of active ingredients, which can result in life-threatening immune responses, hospitalization, severe drug-drug interactions, and overdoses”, it added.
And the Danish pharmaceutical company said that it is “asking the court to permanently ban Hims & Hers from selling unapproved, compounded drugs that infringe [its] patents”, noting that it is also “seeking to recover damages”.
“Dangerous and deceptive”
Novo Nordisk group general counsel John F. Kuckelman said that patient safety “has always been” the company’s “top priority”.
“Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process – that’s dangerous and deceptive to patients, and undermines the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective,” he said.
Read more: Hims & Hers brings weight loss subscription to UK, incl oral option
Hims & Hers, however, told C+D that the lawsuit is a “blatant attack” on “millions of Americans who rely on compounded medications for access to personalized care”.
“Once again, big pharma is weaponizing the US judicial system to limit consumer choice,” it said, adding that the lawsuit “attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care".
“Hims & Hers has a long history of providing safe access to personalized healthcare to millions of Americans, and we will continue to fight to provide choice, affordability, and access,” the company stressed.
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It comes after the American compounding pharmacy Strive filed a lawsuit against Novo Nordisk and Eli Lilly last month for “unlawfully [restricting] competition” for glucagon-like-peptide-1 receptor agonist (GLP-1RA) medicines.
The filing claimed that the companies forestalled “all competition” for GLP-1 medicines, forcing patients to “pay inflated prices and suffer reduced access” to the drugs.
Meanwhile, Hims & Hers announced in December that it had launched a “comprehensive” weight loss programme in the UK.
