Competition in the increasingly crowded obesity treatment market is heating up after Danish pharmaceutical company Novo Nordisk threatened legal action against U.S. telehealth group Hims & Hers Health Inc. for launching a cheaper version of Novo Nordisk's weight-loss drug Wegovy in tablet form.
Hims & Hers announced on Thursday that its new product, priced at $49 per month, contains semaglutide, the same active ingredient found in Wegovy. Novo Nordisk began selling oral Wegovy tablets in the U.S. last month, with the lowest dose priced at $149 per month, marking the world's first approved oral version of a weight-loss medication.
Novo Nordisk responded strongly, labeling the move as "illegal mass compounding" and stating that it poses "significant risks" to patient safety. The company said it will pursue legal and regulatory measures to protect patients and its patent rights.
"This is another example of Hims & Hers misleading the American public with compounded GLP-1 products, following prior warnings from the U.S. Food and Drug Administration regarding their misleading promotion of such products," Novo Nordisk stated.
Hims & Hers offers a compounded version of the weight-loss drug. Compounding involves custom-producing medications using the same active ingredients as branded drugs to replicate the effects of the original product. Compounded drugs are not approved by the FDA.
Novo Nordisk ended its relationship with Hims & Hers last year, citing the latter's misleading marketing of a compounded version of its blockbuster drug Wegovy under the guise of "personalization." Hims & Hers denied the allegations at the time.
Compounded versions of obesity and diabetes drugs gained popularity in 2022 when demand surged and Novo Nordisk and Eli Lilly struggled to meet supply. The FDA had declared these drugs in shortage, allowing pharmacies to produce compounded alternatives to Novo Nordisk's Wegovy and Ozempic, as well as Eli Lilly's Zepbound. The FDA has since stated that these drugs are no longer in short supply.
In September of last year, the FDA sent a letter to Hims & Hers warning that claims on its website suggesting compounded semaglutide products contain "the same active ingredient as Ozempic and Wegovy" and are "clinically proven ingredients" were misleading, as they could imply these products are equivalent to FDA-approved drugs, which they are not.
A spokesperson for Hims & Hers responded to the FDA letter by stating the company's commitment to compliance and transparency.
"We have reviewed promotional materials related to compounded treatments to ensure they meet FDA standards and clearly indicate that these products are not FDA-approved," the spokesperson said.
In a statement, Hims & Hers added that Novo Nordisk's claims were "predictable, outdated, and inaccurate," emphasizing the company's track record of providing "personalized" healthcare services.
"This is not the first time a major pharmaceutical company has claimed that a more accessible, consumer-first healthcare model is dangerous, illegal, or harmful to the market—and it will not be the last," the statement read.
The move adds pressure on Novo Nordisk, which has previously warned that its net sales could decline by up to 13% this year due to increased competition and falling prices in the U.S. market.
Eli Lilly is expected to receive regulatory approval for a tablet version of its popular weight-loss drug Zepbound later this year.
During Thursday trading in New York, shares of Copenhagen-listed Novo Nordisk fell approximately 8%, while Eli Lilly dropped about 7%, and Hims & Hers declined 4%.
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