Hims & Hers responds to FDA pressure, pulls knockoff Wegovy drug launch after regulatory threats

Following threats from the Food and Drug Administration (FDA) that it would take “decisive” action against companies selling “illegal copycat drugs,” telehealth company Hims & Hers announced it would pull the launch of its knockoff Wegovy weight loss drug.

“Since launching the compounded semaglutide pill on our platform, we’ve had constructive conversations with stakeholders across the industry,” Hims & Hers said on Saturday. “As a result, we have decided to stop offering access to this treatment.”

The FDA named checked Hims & Hers in its Friday announcement, saying, “These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.  We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act.”

Hims & Hers’ decision also comes as Novo Nordisk threatened to take legal action over the cheaper version of its weight loss pill, which has not been approved by the FDA or gone through clinical trials.

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Hims & Hers announced Thursday that it would begin selling its compounded version of Novo’s Wegovy at an introductory price of $49 a month, which is around $100 less than the original, and the lowest price for a GLP-1 weight loss drug on the U.S. market.

Compounded drugs involve pharmacies mixing ingredients for certain specialized drugs at different dosages to make a copycat drug. The process has increased in the U.S. as Americans want lower-priced medications.

Shares of Novo first fell after the Hims announcement on Thursday, but then recovered and Hims’ shares fell after the FDA announcement on Friday.

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Hims didn’t say whether it planned to keep selling its compounded GLP-1 injection on its website.

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Novo and Hims previously had a partnership that allowed Hims to sell Wegovy, but Novo pulled out after accusing Hims marketing knockoff Wegovy drugs.

Hims’ CEO Andrew Dudum accused Novo of attempting to control how clinicians at Hims make decisions.

Reuters contributed to this report.