biostudies-literatureUnknown13(5)Seo NAmgen<h4>Introduction</h4>ABP 938 is being developed as a biosimilar candidate to aflibercept reference product (RP), a biologic used for certain angiogenic eye disorders. This study was designed to provide a comparative analytical assessment of the structural and functional attributes of ABP 938 and aflibercept RP sourced from the United States (US) and the European Union (EU).<h4>Methods</h4>Structural and functional characterization studies were performed using state-of-the-art analytical techniques that were appropriate to assess relevant quality attributes and capable of detecting qualitative and quantitative differences in primary structure, higher-order structure and biophysical properties, product-related substances and impurities, general properties, and biological activities.<h4>ResulOphthalmology and therapy1303-1320https://www.ebi.ac.uk/biostudies/studies/S-EPMC11039433biostudies-literatureAnalytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product.PMC11039433Matthies KNg MLiu JWong HYSeo NChung HSHCrouse-Zeineddini JKuhns SKalenian KGuan XPadaki RWang TFoltz INCao SWikstrom MfalseAnalytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product.<h4>Introduction</h4>ABP 938 is being developed as a biosimilar candidate to aflibercept reference product (RP), a biologic used for certain angiogenic eye disorders. This study was designed to provide a comparative analytical assessment of the structural and functional attributes of ABP 938 and aflibercept RP sourced from the United States (US) and the European Union (EU).<h4>Methods</h4>Structural and functional characterization studies were performed using state-of-the-art analytical techniques that were appropriate to assess relevant quality attributes and capable of detecting qualitative and quantitative differences in primary structure, higher-order structure and biophysical properties, product-related substances and impurities, general properties, and biological activities.<h4>Resul2024-01-01T00:00:00Z2024 May2025-04-22T20:43:24.456Z2025-04-06T03:17:41.105ZS-EPMC110394333850718910.1007/s40123-024-00914-1