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FDA flags peptide drugs as a growing area after first generics for liraglutide and tentative semaglutide approval
Summary
Darby Kozak said the office approved the first generic liraglutide for chronic weight management last August and that the agency issued a tentative approval for a first generic semaglutide earlier this month, calling peptide (GLP-1) products a growing market of interest.
In her forum remarks, Darby Kozak highlighted recent first-generic milestones for peptide drugs and signaled more activity to come. She noted the approval last August of the first generic liraglutide indicated for chronic weight management and said, "earlier this month, we saw the tentative approval of the first generic semaglutide ANDA," adding that the agency expects more peptide submissions in coming years.
Kozak framed GLP-1 and peptide products as a rapidly evolving and commercially important area, urging industry and reviewers to anticipate increased submissions and the regulatory challenges associated with complex peptide formulations.
