Telehealth company Hims & Hers has announced that it is abandoning its plan to offer a knockoff version of the weight-loss medication Wegovy. This decision came just two days after the company initially unveiled the new drug offering, and merely one day following a warning from the Food and Drug Administration (FDA) regarding potential restrictions on the ingredients necessary for producing alternatives to popular weight-loss medications.
On Thursday, Hims disclosed its plans to provide a compounded version of Wegovy, a medication recently launched by drugmaker Novo Nordisk. In response, Novo immediately threatened legal action against Hims, prompting the FDA to announce its intention to take significant steps to limit access to the active components of widely used GLP-1 drugs such as Wegovy, Ozempic, and Zepbound.
Despite the announcement from Hims regarding the discontinuation of their compound semaglutide pill, their own website continued to promote the product hours later, which is notable as semaglutide is the active ingredient in Wegovy. Hims stated, “Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry. As a result, we have decided to stop offering access to this treatment.” The company emphasized its ongoing commitment to providing safe, affordable, and personalized care to Americans reliant on their services.
As of now, Hims has not indicated whether it will alter its available compounded versions of injectable weight-loss medications in light of the FDA's actions. The San Francisco-based telehealth firm had intended to significantly reduce the price of Wegovy, which is offered by Novo at $149 for a monthly supply, by selling its version at an introductory rate of $49 for the first month, and $99 for subsequent months. Hims, along with similar companies, emerged several years ago by providing low-cost generic alternatives for medications related to hair loss and erectile dysfunction before expanding into the lucrative market for obesity drugs.
On the other hand, Novo Nordisk plans to promote its newly FDA-approved Wegovy pill with a Super Bowl advertisement featuring several celebrities. While Novo did not immediately comment on Hims' decision to drop its knockoff version, rival pharmaceutical company Eli Lilly expressed its expectations that the FDA would approve an oral variant of its orforglipron weight-loss medication in the upcoming spring. It is worth noting that Wegovy marks the first pill to be introduced to the market in this category.
Importantly, the compounded medication intended for sale by Hims had not been approved by the FDA and had not undergone clinical trials to verify its effectiveness. The FDA permits specialty pharmacies and other entities to create compounded versions of brand-name medications when there is a documented shortage. However, the recent surge in demand for GLP-1 drugs prompted companies like Hims to enter this multibillion-dollar market, capitalizing on patients’ willingness to pay out of pocket for such treatments.
In 2024, the FDA indicated that GLP-1 drugs no longer faced shortages, which was expected to put an end to the compounding practice. Nonetheless, companies such as Hims had been relying on a regulatory exception that allowed them to continue selling their variations of these medications if a prescription was tailored to an individual patient.
