Physicochemical and biologic comparability of a biosimilar granulocyte colony-stimulating factor with its reference product

摘要: Development of biosimilars requires physicochemical and biologic characterization to show comparability with a reference product. Zarzio® (filgrastim) is biosimilar recombinant human granulocyte colony-stimulating factor (G-CSF) that has been approved in the EU using Neupogen® as its The aim this study was compare drug identity, purity, bioactivity (300 480μg/0.5mL solution) Neupogen®, broad range standard advanced analytical methods. Peptide mapping UV detection mass determination, circular dichroism (CD) spectroscopy, nuclear magnetic resonance (NMR) matrix-assisted laser desorption/ionization-time flight (MALDI-TOF) spectrometry liquid chromatography electrospray ionization (LC-ESI) were among analyses used primary higher-order protein structure. Cation-exchange (CEX) reversed-phase high-performance (RP-HPLC) polarity charge. Biologic included comparison G-CSF receptor binding affinity by surface plasmon an vitro cell proliferation assay, Western blot immunologic binding. structures shown be identical peptide other tests. CD NMR spectroscopy demonstrated two products have comparable secondary tertiary structures. RP-HPLC methods showed similar purity profiles. Comparable GCSFR/CD114 obtained assay. These results product, Neupogen®.