Immunogenicity risk assessment of peptide-related impurities identified in generic teriparatide products.

ABSTRACT: Teriparatide is one of several generic peptides named in a recent Food and Drug Administration (FDA) guidance (FDA-2017-D-5767-0002), which outlines a potential strategy to inform immunogenicity risk assessment for synthetic generic peptides without requiring clinical studies. Specifically, the guidance states that for abbreviated new drug applications (ANDAs), once the sameness of the active pharmaceutical ingredient (API) between the generic product and the reference listed drug is established, developers can mitigate the residual risk of unwanted immunogenicity response by using in silico and in vitro tools to characterize differences in product- and process-related impurities between the reference and generic drug products. Regarding product-related impurities, a stated c

SUBMITTER: Mattei AE 

PROVIDER: S-EPMC12722964 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature