While there are a few generic GLP-1s on the market, the major blockbuster medications like Ozempic and Zepbound are still brand-name only.
But companies like Hims & Hers were able to cut into this market when the active ingredient of Ozempic and Wegovy, semaglutide, went into shortage a few years ago. During the shortage, the company was able to start selling compounded versions of the drug, essentially copycat versions, at much cheaper prices.
But when the shortage ended, these companies technically lost the freedom the sell and market compounded semaglutide without a personalized prescription, something compounders fiercely fought against in courts.
As of this week, Hims & Hers is still marketing compounded Ozempic on its website, with the company having previously argued its offering personalized versions of the diabetes and weight loss medication, another permitted function of compounding pharmacies.
But last week, the Department of Health and Human Services Office of the General Counsel referred Hims & Hers to the Justice Department for potential violations of the Federal Food, Drug, and Cosmetics Act.
And on Monday, Novo Nordisk, the manufacturer of semaglutide, announced a lawsuit against Hims & Hers for allegedly "deceiving patients and putting their health at risk."
"On its websites, Hims states that its compounded GLP-1 products contain 'the same active ingredient in the brand-name medication Wegovy® and Ozempic®,' which the websites further describe as semaglutide," the company's lawsuit states.
"Novo Nordisk, however, does not directly or indirectly sell semaglutide API for use in compounding. Instead, Hims markets compounded semaglutide that it admits on its website is 'not approved or evaluated for safety, effectiveness, or quality by the [Food and Drug Administration] FDA.'"
Hims & Hers pushed back in a statement, saying, "Novo Nordisk's lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care.
"This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer," the company added.
"Hims & Hers has a long history of providing safe access to personalized healthcare to millions of Americans, and we will continue to fight to provide choice, affordability, and access."
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