FDA Makes Generic GLP-1 Development a Priority: Article

FDA is making approval of generic GLP-1 drugs a priority as it seeks to increase competition and reduce the cost of the increasingly widely used medicines, CDER director Michael Davis told a recent FDA meeting, according to a report by the Regulatory Affairs Professionals Society (RAPS).

Speaking at a Sept. 23 FDA/Center for Research on Complex Generics meeting, Davis said developing generic GLP-1 products presents significant scientific and regulatory challenges, including characterization of complex peptides, control of impurities and degradation products, and development of injection devices. “We need advanced analytical and computational methods to allow us to characterize complex peptides at a highly detailed level,” Davis said, according to RAPS.

The stakes are high. Davis said U.S. spending on GLP-1 drugs has exceeded $130 billion annually, representing about 14% of prescription drug expenditures. With some patients potentially using the medicines for the rest of their lives, access and affordability have become urgent public health issues, he said.

Legal obstacles may also slow generic competition, according to Wlliam Feldman, associate professor of medicine at UCLA, who pointed to extensive “patent thickets” surrounding GLP-1 drug-device combinations. A 2023 JAMA study co-authored by Feldman identified 188 patents covering 10 FDA-approved GLP-1 drug-device combinations, including 107 device patents.

Despite the challenges, FDA officials said the scientific tools available to evaluate complex generic products have improved substantially over the past decade.