Hims & Hers Launches Cheaper Wegovy Pill Copy, Prompting Legal Threats from Novo Nordisk
Telehealth company Hims & Hers announced on Thursday that it will launch a cheaper, off-brand version of the blockbuster weight-loss pill Wegovy, just weeks after drugmaker Novo Nordisk introduced its highly anticipated reformulation of the medication.
The announcement marks the latest effort by Hims & Hers to capitalise on the surging popularity of GLP-1 drugs like Wegovy, which have revolutionised weight loss treatment across the United States.
For several years, Hims has sold compounded versions of these weight-loss drugs, which were initially available only as injections. Novo Nordisk's Wegovy is the first of these medications to become available in a convenient pill format.
Novo Nordisk Threatens Legal Action Over "Knockoff" Product
The Danish pharmaceutical giant responded to the news by threatening to sue Hims & Hers, labelling 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 stated emphatically.
Despite previous threats and warnings from the Food and Drug Administration, Hims has managed to keep its products on the market due to their status as compounded medications. This class of drugs is customised and not subject to the same stringent federal regulations as approved pharmaceuticals.
Pricing and FDA Warnings Highlight Market Tensions
San Francisco-based Hims & Hers revealed 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 thereafter. This pricing is significantly below Novo Nordisk's monthly cost of $149.
In September, the FDA issued a warning letter to Hims over "false and misleading" marketing language that regulators said suggested its compounded products were equivalent to FDA-approved GLP-1 drugs.
Thursday's announcement from the company states that its pill contains "the same active ingredient as Wegovy," but also clarifies that it is not "approved or evaluated for safety, effectiveness, or quality by the FDA."
Compounding Loophole and Personalised Medicine Claims
The FDA permits specialty pharmacies and other companies to produce compounded versions of brand-name drugs when they are in short supply. The booming demand for GLP-1 drugs in recent years has prompted companies like Hims to enter the multibillion-dollar market, with many patients willing to pay cash for these treatments.
Beginning in 2024, the FDA announced that GLP-1 drugs were no longer in shortage, a step expected to curtail compounding activities. However, an exception remains: the practice is still permitted when a prescription is customised for an individual patient.
Hims and other companies argue they offer "personalised" 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 personalisation," said Dr. Craig Primack, who heads weight-loss products at Hims, in a statement on Thursday.
Shares of Novo Nordisk A/S fell more than 5% in afternoon trading on Thursday, reflecting market concerns over the competitive threat posed by the cheaper alternative.
