The maker of Ozempic is trying to block synthetic versions of its blockbuster drug
Drugmaker Novo Nordisk is taking action to limit it Widely available mixed semaglutide industrywhich offers copies of the blockbuster weight-loss drugs Ozempic and Wegovy to patients—often at much lower prices.
The Danish pharmaceutical company is lobbying the U.S. Food and Drug Administration to add semaglutide to the agency’s Distinct Dispensing Difficulties (DDC) list, which would prevent pharmacies from compounding manufacturing counterfeit drugs. in one The filing was posted by the agency on TuesdayNovo Nordisk’s lawyers reasoned that semaglutide was on the list “due to the complexity associated with their formulation,” among other reasons.
“These medications are inherently complex to prepare safely, and the risks they pose to patient safety far outweigh any benefits. Novo Nordisk’s intent with this nomination is to ensure that patients only receive FDA-approved, safe and effective semaglutide products,” said Novo Nordisk director of media relations Jamie Bennett.
FDA press officer Amanda Hils told WIRED via email that the agency “is reviewing the petition and will respond directly to the petitioner.”
If granted, this designation would have seismic implications for the compounding industry — and for the millions of people currently using compounded GLP-1 drugs.
GLP-1 injections including semaglutide and tirzepatide have been in short supply since 2022 because they enormous popularity. In the United States, when the FDA declares that a certain drug is in short supply, certain licensed pharmacies are authorized to produce “compounded” versions of that drug, which are mixed in-house and believed to contain the same active ingredients as the original drug.
Telemedicine providers have taken advantage of the shortage of the GLP-1 drug, offering patients compounded versions via Quick virtual appointment. This practice has created tension with pharmaceutical companies that produce brand-name drugs because the compounded form of the drug is sold at a much lower price. Ozempic and Wegovy can cost about $1,000 a month without insurance, while compounded semaglutide is advertised online for as little as $100 a month.
Unlike generic drugs, which are produced after the drug’s patent expires, compounded drugs do not have to be approved by the FDA before hitting the market. This means that the FDA cannot guarantee the safety, effectiveness, or quality of compounded drugs before they are sold to patients. FDA received Many reports of adverse side effectsincluding hospitalization, related to possible dosing errors associated with semaglutide compounded products.
