（Singapore, 06.02.2026）U.S. regulators have warned they are ready to crack down on companies selling what they call “illegal copycat drugs,” a move that sent shares of telehealth firm Hims and Hers Health sharply lower and reignited tensions across the fast-growing weight-loss drug market.
The warning came after Hims launched a low-cost, compounded version of a new oral weight-loss pill made by Novo Nordisk, pricing it at just $49 for the first month. That price is far below Novo’s own branded version of the pill, which debuted in January at $149 for first-time users and $199 thereafter.
The U.S. Food and Drug Administration said it is closely watching companies that mass-market unapproved drugs by suggesting they are similar to FDA-approved treatments. FDA Commissioner Marty Makary said the agency would take “swift action” against such practices, noting that the regulator cannot verify the safety, quality, or effectiveness of drugs that have not gone through its approval process.
Although Makary did not name any specific company, investors reacted quickly. Hims shares, which had already fallen during regular trading, dropped about 10% in after-hours trading following the comments. Earlier in the day, the announcement of Hims’ cheaper pill had also triggered a selloff in Novo and Eli Lilly, the two dominant players in the booming market for weight-loss drugs.
At the center of the dispute is Hims’ decision to sell a compounded version of Novo’s oral Wegovy pill. Compounded drugs are made by pharmacies that mix ingredients to tailor medications for individual patients or, in some cases, to replicate existing drugs at different doses or formulations. These products are not FDA-approved and do not undergo large clinical trials.
Hims argues that its offering expands access to weight-loss treatment for millions of Americans who cannot afford branded medications. The company says its pill uses a liposome-based technology designed to support absorption and that it has not compromised on safety or effectiveness.
Novo strongly disagrees. The Danish drugmaker says Hims’ mass production and marketing of a copycat pill is illegal and threatens both patient safety and the integrity of the U.S. drug approval system. Novo’s chief executive has called the cheaper pill “a waste of money,” arguing that Novo’s own product uses proprietary technology that improves how the medicine is absorbed by the body.
In an emailed statement after the FDA comments, Novo said it is working with regulators, law enforcement, and other stakeholders to protect patients from unapproved knockoff drugs and to ensure access to safe, effective, FDA-approved treatments. The company has also said it is prepared to take legal action to defend its intellectual property.
The clash highlights a growing fault line in the U.S. healthcare system. Demand for weight-loss drugs has surged, but high prices and limited insurance coverage have pushed many patients to seek cheaper alternatives. Compounding pharmacies have stepped into that gap, offering lower-cost versions of popular drugs while staying within or testing the boundaries of FDA rules.
The FDA has previously warned Hims about its marketing practices. In September, the agency said claims such as “same active ingredient as Ozempic and Wegovy” were misleading, because compounded drugs are not the same as FDA-approved products and are subject to far less oversight. Ozempic, like Wegovy, is based on semaglutide, a GLP-1 drug originally developed to treat diabetes.
Hims and Novo have been locked in an on-and-off dispute since 2023, when the FDA allowed Hims to sell compounded versions of Novo’s injectable GLP-1 drugs during a period of shortages. Since then, Hims has continued to offer what it calls “personalized” versions of branded medicines, with adjusted doses or treatment regimens.
The two companies briefly partnered in 2025, allowing Hims to offer injectable Wegovy, but the agreement collapsed within months. Novo accused Hims of improperly marketing its medicines, while Hims said Novo was trying to interfere with how its clinicians make treatment decisions.
Market watchers say the latest episode underscores how sensitive investors are to regulatory risk in the digital health and compounding space. Hims’ stock has been highly volatile, surging and plunging repeatedly over the past two years. Nearly a third of its shares are currently on loan for short-selling, reflecting skepticism about the sustainability of its business model.
Meanwhile, competition in the oral weight-loss market is only intensifying. Eli Lilly is expected to launch its own pill later this year and has pledged affordable pricing through government-backed programs. Some analysts believe Lilly’s drug could become the next target for compounded copies, potentially drawing further scrutiny from regulators.
For now, the FDA’s warning has sent a clear signal: while innovation and affordability are welcome, companies that push too far in marketing unapproved drugs may face enforcement action. As regulators, drugmakers, and telehealth firms square off, patients and investors alike are left watching closely to see where the line will be drawn.
