Hims & Hers launches Wegovy knockoff 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 highly anticipated reformulation of the blockbuster medication.

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

For years, Hims has sold compounded versions of the weight-loss drugs, which were initially only available as injections. Novo Nordisk’s Wegovy is the first of the medications to become available in a pill format.

The Danish drugmaker responded to the news Thursday by vowing to sue Hims, calling the new product “an unapproved, inauthentic, and untested knockoff” 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 been able to keep its products on the market due to their status as compounded medications, a class of drugs that are customized and aren’t subject to strict federal regulations.

San Francisco-based Hims said it will launch its compounded pill at $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 issued a warning letter to Hims over “false and misleading” marketing language which regulators said suggested its compounded products were the same as FDA-approved GLP-1 drugs.

Thursday’s announcement from the company states that its pill contains “the same active ingredient as Wegovy,” but also mentions that is it not “approved or evaluated for safety, effectiveness, or quality by the FDA.”

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

Beginning in 2024, FDA began announcing that GLP-1 drugs were no longer in a shortage, a step that was expected to put an end to the compounding. But there is an exception: The practice is still permitted when a prescription is customized for the patient.

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

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

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

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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.