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Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics
BioDrugs (04/03/2015) Sörgel, F.; Schwebig, A.; Holzmann, J.
There is strong evidence of structural and functional similarity between the proposed biosimilar filgrastim (EP2006) and the U.S.-approved originator filgrastim, according to a new study. Researchers used protein analytical techniques to compare the physicochemical properties of EP2006, U.S.-approved originator filgrastim, and E.U.-approved originator filgrastim. The randomized, phase I study in healthy volunteers assessed the pharmacodynamics, pharmacokinetics, and safety profiles of EP2006 and U.S.-approved originator filgrastim, administered as a single injection. EP2006 and originator filgrastim were highly similar in primary, secondary, and tertiary protein structures; mass, size, purity, charge, and hydrophobicity. There were no observed differences in receptor binding affinity, and all samples demonstrated similar in vitro bioactivity. The phase I study showed no statistically significant differences between EP2006 and originator filgrastim in pharmacodynamic or pharmacokinetic parameters, and the two products had similar safety profiles.
Abstract News © 2015 INFORMATION, INC.
