Hims, long flying under regulators’ radar, finally strikes a nerve with its Wegovy pill copy

Novo Nordisk CEO Mike Doustdar appeared to learn in real time on Thursday that Hims & Hers — a thorn in Novo’s side for more than a year — planned to sell copies of his company’s new oral weight-loss drug.

Hims announced it would sell a starter dose for $49 per month, compared with Novo’s $149 cash-pay price. Doustdar was asked about the move during a call with analysts, just days after Novo gave a devastating full-year outlook and said competition and price pressure were weighing on sales.

“You’re wasting $49, in my opinion,” Doustdar said. Hours later, Novo released a statement threatening “legal and regulatory action” against Hims. 

By Thursday evening, the dispute appeared to escalate. FDA Commissioner Marty Makary said in an X post that the agency would “take swift action against companies mass-marketing illegal copycat drugs.”

Hims has doubled down on selling copies of Novo’s GLP-1s even as many of its peers have opted to instead forge partnerships with the drugmaker. For the most part, Hims has gotten by without more than a slap on the wrist by the FDA. This product launch may be the tipping point.

Does it even work? 

A key question emerged regarding how Hims, or its partner pharmacy, Strive, could create a copy of Novo’s Wegovy pill that actually works. 

While Wegovy is best known as a once-weekly injection, Novo spent billions of dollars developing oral versions using proprietary delivery technology. Developing these drugs as pills rather than injections, and therefore widening the population of people willing to take the very lucrative drugs, has been a significant challenge for drug manufacturers because the digestive system is built to break down protein-based compounds like GLP-1s.

Novo spent $1.8 billion in 2020 to acquire Emisphere Technologies for its oral drug delivery technology, SNAC, which it uses in its oral semaglutide drugs, including Rybelsus and the Wegovy pill. The patented coating protects the drug from stomach acid — and even then, patients must take it on an empty stomach and wait 30 minutes before eating for it to work.

Like all branded medications, it went through years of clinical trials, and remains the only oral semaglutide delivery method that has been validated in large clinical trials.

A Hims spokesperson told Sherwood News that its pill uses “liposomal technology that is intended to support absorption.” There is no publicly available clinical trial data showing the method works for semaglutide. Strive’s website cites studies done on animals to back up the delivery method. 

Neither Hims nor Strive responded to questions about data backing that this delivery method works. Mochi Health, another telehealth company that markets a compounded oral semaglutide pill and has different pharmacy partners, also did not answer questions about its delivery method. 

“They are conducting quasi-clinical trials on people,” said Dr. Ashwin Sharma, author of the newsletter GLP-1 Digest and a former medical strategy lead at HeliosX, a health tech company.

Shantanu Gaur, CEO of Allurion, a medical technology company, noted on X that since Novo “went to great lengths to use SNAC instead, there must be a reason.” TJ Parker, a cofounder of PillPack, which is now part of Amazon Pharmacy, said the copycat drug “almost certainly doesn’t work.”

Personalization

Hims and other telehealth companies began selling copies of Novo’s injectable weight-loss drug in 2024 while it was in a shortage. Even after the shortage ended, Hims continued to sell copies it says are “personalized” for patients, using a loophole typically reserved for rare situations, such as a patient allergy to a noncritical ingredient in a medication.

Hims aligns with the Trump administration’s policy priorities in several ways: it is putting downward pricing pressure on popular drugs and promotes a populist vision of a healthcare system that cuts insurers out and gives patients autonomy. 

But its Wegovy pill dupe may have been a step too far. Even some Hims’ peers appeared concerned about the company selling pills that potentially don’t work. Its personalization explanation also become more complicated with pills.

Tablets are typically manufactured in batches using a press, while injectable drugs can be customized simply by adjusting the dose in a vial.

“This is really stretching the limits of that exemption past its breaking point,” said Michael Botta, president and cofounder of Sesame, a telehealth platform that partners with Novo.

Novo and Lilly have sued smaller companies under various statutes, largely unsuccessfully. Though the FDA gave Hims a warning letter in November, until Makary’s post Thursday, it had not signaled it was an enforcement priority. 

Hims does not make the pill itself — Strive does — potentially limiting the company’s own legal liability.

“I do think there’s a reason they [Novo] haven’t gone after Hims, which is that there is a substantial risk they lose,” said Michael Schnell, a consumer health expert at West Monroe. “And if you lose that and you set the precedent, then it’s going to be very hard to unwind it.”