Drugmaker Novo Nordisk is taking motion to curb the massively standard compounded semaglutide trade, which supplies copies of its blockbuster weight-loss medicine Ozempic and Wegovy to sufferers—typically for a lot decrease costs.
The Danish pharmaceutical firm is lobbying the US Meals and Drug Administration so as to add semaglutide to the company’s Demonstrable Difficulties for Compounding (DDC) lists, which might block compounding pharmacies from producing dupes of the drug. In a submitting posted by the company on Tuesday, legal professionals for Novo Nordisk cause that semaglutide belongs on the these lists “because of the complexities related to their formulations,” amongst different causes.
“These medicine are inherently complicated to compound safely, and the dangers they pose to affected person security far outweigh any advantages. Novo Nordisk’s purpose with this nomination is to make sure that sufferers obtain solely FDA-approved, protected, and efficient semaglutide product,” says Novo Nordisk director of media relations Jamie Bennett.
FDA press officer Amanda Hils informed WIRED by way of e mail that the company “is reviewing the petition and can reply on to the petitioner.”
If granted, the designation would have seismic implications for the compounding trade—and for the seemingly thousands and thousands of individuals at the moment taking compounded GLP-1 medicine.
Injectable GLP-1 medicine together with semaglutide and tirzepatide have been in scarcity since 2022 due to their big reputation. Within the US, when the FDA declares {that a} drug is in scarcity, sure licensed pharmacies are permitted to make “compounded” variations of the medicine, that are combined in-house and are alleged to include the identical lively substances as the unique drug.
Telehealth suppliers have capitalized on the GLP-1 drug scarcity, providing sufferers compounded variations by way of fast digital appointments. The follow has created stress with the pharmaceutical firms that make the brand-name medicine for the reason that compounded variations are bought at a lot decrease costs. Ozempic and Wegovy can value round $1,000 a month with out insurance coverage, whereas compounded semaglutide is marketed for as little as $100 a month on-line.
Not like generic drugs, that are manufactured after drug patents expire, compounded drugs usually are not topic to FDA approval earlier than hitting the market. Which means that the FDA can’t vouch for the protection, effectiveness, or high quality of compounded medicine earlier than they’re bought to sufferers. The FDA has acquired a number of reviews of antagonistic negative effects, together with hospitalization, associated to doable dosing errors related to compounded semaglutide merchandise.
