Aniket PujariShares of Novo Nordisk rose more than 5% in pre-market trading on Friday, after Hims & Hers Health launched a compounded semaglutide pill, which came under scrutiny following an FDA warning against illegal copycat weight-loss drugs.
Just a day earlier, Hims & Hers Health announced that it will begin offering a lower-priced version of the new weight-loss pill. The news led to Novo’s shares dipping as much as 7.5% on Thursday’s trading session.
According to a report by Reuters, the telehealth firm said it will sell a copycat version of the drug starting at $49 a month through a subscription programme, whereas Novo sells the branded version, named Wegovy, for $149 a month.
FDA warns of strict action
Following the announcement, FDA Commissioner Marty Makary took to social media to issue a strict warning to drugmakers that offer such copycat products.
“FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” he wrote on X (formerly Twitter).
He further added that “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs”.
Novo pushes back against copycat drugs
Within hours of Hims and Hers Health’s announcement, Novo also issued a statement, saying that it would take legal action against the company in the interest of patients, its intellectual property, and the US drug approval framework, Reuters reported.
“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety,” the Danish drugmaker said in a statement, adding that Novo is the only company producing an FDA-approved Wegovy capsule.
Hims and Hers Health responds to criticism
In view of the sharp criticism, Hims and Hers Health also issued a rebuttal on X. “Our track record speaks for itself and is why we’ve been able to help nearly 2.5M customers access care personalized to their needs. We’re focused on bringing more access, more positive outcomes, and more choice to customers everywhere,” it said.
The drug-maker also said that this was not the first time a large pharmaceutical company had claimed that its customer-first approach is dangerous or illegal. “This narrative is as predictable as it is outdated and false,” it noted in the social media post.
FDA’s advisory to consumers
In a separate press release on Wednesday, the FDA said that unapproved versions of GLP-1 drugs such as Semaglutide and Tirzepatide are sold without adhering to FDA review of safety, effectiveness, and quality prior to marketing.
The FDA noted that compounded GLP-1 drugs should only be used only when medically necessary, and only in cases where a patient’s needs cannot be met with an FDA-approved product.
The agency also warned about risks such as improper storage, dosing errors, and fraudulently sold products. As of 31 July 2025, the FDA said it has received 605 adverse event reports linked to compounded Semaglutide and 545 reports associated with compounded Tirzepatide, adding that these figures are likely underreported.
