Hims & Hers launches Wegovy knock-off pill, Novo Nordisk vows to sue

WASHINGTON (AP) — Telehealth company Hims & Hers said Thursday it will launch a cheaper, off-brand version of the weight-loss pill Wegovy, just weeks after drugmaker Novo Nordisk launched its long-awaited reformulation of the blockbuster drug.

Hims’ announcement is the latest example of the company’s efforts to capitalize on the growing popularity of GLP-1 drugs like Wegovy, which have revolutionized weight loss treatment in the US.

Hims has been selling compounded versions of the weight-loss drugs for years, which were initially only available as an injection. Wegovy from Novo Nordisk is the first drug to become available in pill form.

The Danish drugmaker responded to the news Thursday by promising to sue Hims, calling the new product “an unapproved, unauthentic and untested knock-off” of semaglutide, the chemical name for Wegovy.

“Novo Nordisk will take legal and regulatory action to protect patients, our intellectual property and the integrity of the U.S. gold standard drug approval framework,” the company said in a statement.

Despite previous threats and warnings from the Food and Drug Administration, Hims has managed to keep its products on the market due to their status as compounded medications, a class of medications that are tailor-made and not subject to strict federal regulation.

San Francisco-based Hims said it will launch its compounded pill for $49 for the first month as part of an introductory offer for new customers, followed by $99 per month. That’s well below Novo’s price of $149 per month.

In September, the FDA sent a warning letter to Hims over “false and misleading” marketing language that regulators said made its compounded products the same as FDA-approved GLP-1 drugs.

The company’s Thursday announcement states that the pill “contains the same active ingredient as Wegovy,” but also notes that the pill has not been “approved or evaluated for safety, effectiveness, or quality by the FDA.”

The FDA allows specialty pharmacies and other companies to make compounded versions of brand-name drugs when they are in short supply. And booming demand for GLP-1 drugs in recent years has pushed companies like Hims to enter the multibillion-dollar market for these drugs, with many patients willing to pay cash.

Starting in 2024, the FDA began announcing that there was no longer a shortage of GLP-1 drugs, a move that was expected to put an end to compounding. But there is an exception: the practice is still allowed if a prescription is tailor-made for the patient.

Hims and other companies say they offer “personalized” dosages and formulations of GLP-1 drugs that will benefit patients.

“Whether a patient needs a specific dose adjustment or prefers a compounded semaglutide pill over an injection, our platform now supports a deeper level of personalization,” says Dr. Craig Primack, head of weight-loss products at Hims, said in a statement Thursday.

Shares of Novo Nordisk A/S fell more than 8% on Thursday afternoon.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.