As many as one of the GLP-1 anti-obesity drugs, but a surprising number aren鈥檛 getting their supplies from pharma giants Novo Nordisk or Eli Lilly. Up to 30 percent of the market, by some estimates, is made up of copycat versions from compounding pharmacies.
Compounding is legal, though the resulting products sometimes fall into a gray area because they鈥檙e copies of drugs under patent and are not approved by the Food and Drug Administration.
Mark Mikhael, CEO of Orlando-based Olympia Pharmaceuticals, estimates that his and other large compounders provision up to 2 million Americans each month with semaglutide, the scientific name for Novo Nordisk鈥檚 Wegovy, Ozempic and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly鈥檚 Zepbound and Mounjaro.
Many of the compounded drugs are produced for and sold by online pharmacies like Hims & Hers Health, Henry Meds and Ro. Others come from smaller compounding companies.
Novo Nordisk and Lilly fiercely oppose these sales and lump the compounders together with unregulated medical spas peddling bogus semaglutide. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them.
When there鈥檚 a drug shortage 鈥 the FDA has put semaglutide and tirzepatide on shortage lists since 2022 鈥 the agency allows compounders to make it. The compounding companies get raw material for the drugs from mostly Chinese businesses that are registered and, at least in theory, inspected by the FDA.
Because the drugs are not strictly FDA-approved, those who make, prescribe or take them should exercise 鈥渁n increased level of responsibility or awareness,鈥 FDA spokesperson Amanda Hils said.
But she distinguished the compounded drugs from unregulated powders sold as 鈥済eneric Ozempic鈥 and the like, which may be contaminated or counterfeit. The agency recently of the compounds, but it hasn鈥檛 received a disproportionate number of side effect reports linked to these drugs.
Semaglutide and tirzepatide have registered unprecedented success in weight loss. They are also showing promise against heart, kidney and liver diseases, and are being tested to treat or prevent Alzheimer鈥檚 disease and drug addiction. It鈥檚 no wonder they are in shortage.
While most compounded drugs are copies of old, cheap generics, semaglutide and tirzepatide are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Compounded forms are cheaper, particularly for patients whose insurers won鈥檛 cover the branded drugs.
While the pharmaceutical giants can鈥檛 keep up with demand, they dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was 鈥渄eeply concerned鈥 about 鈥渟erious health risks鈥 from compounded drugs that 鈥渟hould not be on the market.鈥
Mikhael鈥檚 company is an outsourcing facility, or 503B compounding pharmacy 鈥 regulated directly by the FDA. Smaller 503A pharmacies are largely overseen by state boards of pharmacy.
The compounders are defiant, calling the diabetes and diet drugs essential products.
鈥淚f you don鈥檛 want a 503B facility to make a copy, it鈥檚 pretty simple: Don鈥檛 go short,鈥 said Lee Rosebush, chair of a trade association for 503B pharmacies. 鈥淔DA created this system because these are necessary drugs.鈥
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