Shares of Novo Nordisk rose greater than 5% in pre-market buying and selling on Friday, after Hims & Hers Well being launched a compounded semaglutide tablet, which got here underneath scrutiny following an FDA warning towards unlawful copycat weight-loss medicine.
Only a day earlier, Hims & Hers Well being introduced that it’ll start providing a lower-priced model of the brand new weight-loss tablet. The information led to Novo’s shares dipping as a lot as 7.5% on Thursday’s buying and selling session.
In line with a report by Reutersthe telehealth agency stated it is going to promote a copycat model of the drug beginning at $49 a month by way of a subscription programme, whereas Novo sells the branded model, named Wegovy, for $149 a month.
FDA warns of strict motion
Following the announcement, FDA Commissioner Marty Makary took to social media to challenge a strict warning to drugmakers that provide such copycat merchandise.
“FDA will take swift motion towards corporations mass-marketing unlawful copycat medicine, claiming they’re much like FDA-approved merchandise,” he wrote on X (previously Twitter).
He additional added that “The FDA can’t confirm the standard, security, or effectiveness of non-approved medicine”.
Novo pushes again towards copycat medicine
Inside hours of Hims and Hers Well being’s announcement, Novo additionally issued an announcement, saying that it might take authorized motion towards the corporate within the curiosity of sufferers, its mental property, and the US drug approval framework, Reuters reported.
“The motion by Hims & Hers is prohibited mass compounding that poses a big danger to affected person security,” the Danish drugmaker stated in an announcement, including that Novo is the one firm producing an FDA-approved Wegovy capsule.
Hims and Hers Well being responds to criticism
In view of the sharp criticism, Hims and Hers Well being additionally issued a rebuttal on X. “Our observe document speaks for itself and is why we’ve been in a position to assist almost 2.5M prospects entry care customized to their wants. We’re targeted on bringing extra entry, extra optimistic outcomes, and extra option to prospects all over the place,” it stated.
The drug-maker additionally stated that this was not the primary time a big pharmaceutical firm had claimed that its customer-first strategy is harmful or unlawful. “This narrative is as predictable as it’s outdated and false,” it famous within the social media publish.
FDA’s advisory to shoppers
In a separate press launch on Wednesday, the FDA stated that unapproved variations of GLP-1 medicine akin to Semaglutide and Tirzepatide are bought with out adhering to FDA evaluate of security, effectiveness, and high quality previous to advertising.
The FDA famous that compounded GLP-1 medicine ought to solely be used solely when medically obligatory, and solely in circumstances the place a affected person’s wants can’t be met with an FDA-approved product.
The company additionally warned about dangers akin to improper storage, dosing errors, and fraudulently bought merchandise. As of 31 July 2025, the FDA stated it has obtained 605 adversarial occasion studies linked to compounded Semaglutide and 545 studies related to compounded Tirzepatide, including that these figures are possible underreported.