| |  | The Lead Brief | The war for market share in the GLP-1 weight loss drug marketplace is being taken up a notch, as telehealth platform Hims & Hers Health on Thursday launched a copycat version of the Wegovy pill — priced at just $99 a month. Novo Nordisk, which makes Ozempic and Wegovy, quickly vowed retribution and called the offering “illegal.” Novo Nordisk said it would take “legal and regulatory action” against the telehealth company, arguing the new product infringed on its intellectual property and could endanger patients. The company did not respond to an inquiry about which regulatory actions it planned to take against Hims & Hers. This isn’t the first time the two companies, which had once partnered with each other, have had a falling out. More on that below. → While companies such as Hims & Hers say that the products are made in factories that are registered with the FDA, the actual compounded GLP-1 medications aren’t evaluated by federal regulators for safety or efficacy. The FDA warned Hims & Hers over its marketing of compounded GLP-1 products last year, arguing the company had used misleading language. The Department of Health and Human Services, which oversees the Food and Drug Administration, didn’t respond to a request for comment about the new product. Why it matters: This new offering could be a major test of how far companies that offer compounded GLP-1 products can go in skirting Big Pharma’s pricing and patent power in the ultracompetitive market for weight loss drugs. Compound pharmacies make individualized versions of medication, such as turning a drug into a liquid for people who have trouble swallowing pills. But as the demand for weight loss drugs has grown, it’s created a new cottage industry for compounders. These companies use the active ingredient in GLP-1 meds — semaglutide, in Novo Nordisk’s case — to make knockoff formulations with different dosage amounts or additions such as vitamins. By making a small number of personalized medications for patients, compound pharmacies have been able to provide their own versions of the GLP-1 drugs that are otherwise protected by patents. “This new offering is firmly rooted in the trusted U.S. regulatory framework for compounding, which has long served as a vital lifeline when mass-manufactured medications do not meet a patient’s unique clinical needs,” Deb Autor, the chief policy officer for Hims & Hers, tells me. The compounded GLP-1 copycats are sold at a fraction of the cost of the name-brand versions, which are still patent protected. Novo Nordisk’s Wegovy pill, which launched last month, costs $149 per month. The company’s CEO, Mike Doustdar, told CNBC on Wednesday that 170,000 people were already taking it in the first four weeks. “Mass compounding of new medicines weeks after their approvals undermines public health and the entire drug review and approval framework,” said Chanse Jones, a spokesperson for the Pharmaceutical Research and Manufacturers of America, the industry group that represents large drugmakers including Novo Nordisk. “The FDA and other policymakers should take immediate action to ensure the integrity of the FDA’s rigorous regulatory review and approval process,” Jones said. Telehealth companies and the compound pharmacies making personalized GLP-1s have drawn lawsuits from drugmakers. “This is not the first time (nor will it be the last time) a big pharma company has suggested taking an accessible, customer-first approach to healthcare [that] is dangerous, illegal, or bad for the marketplace,” Hims and Hers said in a statement on social media. “This narrative is as predictable as it is outdated and false.” | 
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