Hims & Hers pulls Wegovy’s copycat drug after FDA regulatory threat


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

“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 called Hims & Hers verified in its announcement Friday, saying, “These actions are intended to protect consumers from drugs whose quality, safety, or effectiveness the FDA cannot verify. We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act.”

The 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.

NEW WEGOVY PILL OFFERS NEEDLE-FREE WEIGHT LOSS, BUT MAY NOT WORK FOR EVERYONE

The New York Stock Exchange with a Hims and Hers banner

Hims & Hers Health, Inc. is listed outside the New York Stock Exchange on January 21, 2021. (Reuters/Carlo Allegri/Reuters)

Hims & Hers announced Thursday that it would begin selling its composite version of Novo’s Wegovy at a starting price of $49 a month, which is about $100 less than the original, and the lowest price for a GLP-1 weight loss drug in the US market.

Ticker security last change % change
HE HIMS & HERS HEALTH INC 23.02 -0.46

-1.96%

Compounding drugs involves pharmacies mixing ingredients for certain specialty drugs at different doses to make a copycat drug. The process has increased in the US as Americans want lower-priced drugs.

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

PFIZER CEO faces growing competition in weight-loss drugs

Novo Nordisk sign

Headquarters of the pharmaceutical company Novo Nordisk in Bagsvaerd, Copenhagen, Denmark. (Reuters/Tom Little/File Photo)

Hims did not say whether it planned to continue selling its GLP-1 compound injection on its website.

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

Hims CEO Andrew Dudum accused Novo of trying to control how Hims doctors make decisions.

Reuters contributed to this report.



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