Novo Nordisk Sues Hims & Hers Over Knock-off Wegovy Drugs

Wegovy-maker Novo Nordisk has had enough of copycat versions of its popular weight-loss drugs and is suing one of the biggest telehealth companies.Novo announced Monday that it has filed a patent infringement suit against Hims & Hers over its compounded semaglutide products. The lawsuit claims Hims is “duping” consumers over the clinical benefits of its knock-off drugs.Hims announced the launch of a compounded GLP-1 pill last week but abruptly pulled it from the market after a warning from the Food and Drug Administration. Federal regulators said they plan to restrict GLP-1 ingredients in non-FDA-approved versions. A news release announcing the crackdown specifically referenced Hims.Companies are not permitted to claim that non-FDA-approved compounded products are generic versions or the same as approved drugs. “We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act,” the FDA said in the release.Novo announced a pill version of Wegovy last year and it went on sale in January. It is the first and only FDA-approved GLP-1 pill for weight loss. Eli Lilly plans to launch a pill form of its Zepbound weight loss drug in the next few months.Despite pulling its pills, Hims still sells injectable versions of its compounded semaglutide products that cost considerably less than the name brand versions. Novo claims testing shows injectables compounded by pharmacies contain high levels of impurities. “Even in small quantities, such impurities can negatively impact the safety and efficacy of a drug product, including unwanted immune responses like anaphylactic shock,” Novo said in a news release.Novo had a short partnership with Hims last year to provide direct access to Wegovy to its patients but quickly backed out, claiming the company engaged in deceptive promotion and sales of illegitimate, knockoff versions of Wegovy at the same time.In 2022, the FDA had allowed compounded versions of the GLP-1 drugs, originally intended to treat type-2 diabetes, to be sold through telehealth services due to demand far outstripping supply. Last April, the FDA ended the emergency rules that allowed the knock-off versions after finding that Novo was fully able to meet demand.Compounding pharmacies were required to stop making the alternate versions of the GLP-1 drugs in May, but companies like Hims are sidestepping the FDA by offering bespoke copies of the weight-loss compounds by incorporating additives like vitamin B12 into the drug, making their versions different enough so that they can be compounded legally.Novo hopes to gain market share back from Eli Lilly which is becoming the dominant weight loss drugmaker with its Zepbound injectable. Studies have shown Zepbound outperforms Wegovy for weight loss.The market for weight loss drugs is big and expanding but cost concerns remain an issue for its continued growth. About one in eight adults say they are currently taking a GLP-1 drug to lose weight or treat a chronic condition, according to a KFF Health Tracking Poll. BMO Capital markets has predicted the global market for weight-loss drugs will reach $100 billion by 2035.Many insurance companies — including those under the Affordable Care Act — have balked at covering the drugs, however, because of their high prices. The drugs have been too expensive for many patients to pay out-of-pocket — especially on a long-term basis. President Trump reached a deal last year with Novo and Lilly to significantly lower the prices for Medicare and Medicaid patients. Out-of-pocket costs for those patients will be capped at approximately $50 a month.

Novo Nordisk Sues Hims & Hers Over Knock-off Wegovy Drugs

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