Hims & Hers in Hot Water Over Knockoff Version of Wegovy Weight Loss Pills

The maker of the popular weight loss drug Wegovy is threatening to sue a popular tele-health company over a knock-off version of a new pill form of the drug.Hims & Hers Health announced on Thursday that it would begin offering compounded semaglutide pills with the same active ingredient as Wegovy. The company already sells an injectable version of the compounded drug.The tele-health company is undercutting Wegovy’s prices, offering starter doses for as little as $49. That compares with $149 for Wegovy’s starter doses. Novo Nordisk, which manufactures Wegovy, calls the new pills unlawful and an “unapproved, inauthentic, and untested knockoff.”“The action by Hims & Hers is illegal mass compounding that poses a significant risk to patient safety,” Novo said in a statement. “This is another example of Hims & Hers’ historic behavior of duping the American public with knock-off GLP-1 products, and the FDA has previously warned them about their deceptive advertising of GLP-1 knock-offs.”Novo says it is planning to take legal action to protect Wegovy.Compounded versions of brand-name drugs are produced by third parties to mimic the effects of the Food and Drug Administration-approved originals. Hims & Hers says it adheres to all applicable federal and state regulatory standards for compounding but acknowledges its drugs are not FDA approved.Novo had a short partnership with Him & Hers 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 & Hers 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.The long anticipated oral version of the medication is expected to expand the number of patients using them because some people who shied away from self-administered shots are expected to take the pill form.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.An oral version of Zepbound is not expected to hit the market until the spring, giving Novo an edge. Competition from compounded versions could dull that advantage.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.

Hims & Hers in Hot Water Over Knockoff Version of Wegovy Weight Loss Pills

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