On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to include semaglutide in the FDA’s Demonstrable Difficulties for Compounding (DDC) list. The request aims to prevent compounding pharmacies from producing copied versions of Ozempic® (marketed for type 2 diabetes) and Wegovy® (for weight management), both of which comprise semaglutide.
Novo Nordisk argues that semaglutide is challenging to produce safely due to its complex formulation involving yeast-based recombinant DNA technology. Furthermore, compounded versions lack clinical testing, exhibit different impurity profiles, and have raised safety concerns. This is consistent with alerts issued by the FDA to US healthcare providers in July 2024 in relation to risks associated with compounded semaglutide, and the position taken by the Australian Therapeutic Goods Administration (TGA) which has banned compounded copies of Ozempic® since 1 October 2024 due to serious safety concerns.
Competitor Eli Lilly is similarly pushing back against compounded versions of its weight-loss drug Mounjaro® (tirzepatide), filing lawsuits against retailers Pivotal Peptides, MangoRx and Genesis Lifestyle Medicine of Nevada for selling unauthorised compounded formulations. Notably, compounded tirzepatide is also banned in Australia as of 1 October 2024.