Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics

• DOI: 10.1007/s40259-015-0124-7
• Publication Date: 2015-04-03T17:47:59Z
• Authors: Fritz Sörgel; Arnd Schwebig; Johann Holzmann; Stefan Prasch; Pritibha Singh; Martina Kinzig
• Keywords: Biosimilar; Pharmacodynamics; Comparability

Biosimilars provide safety, purity, and potency similar to those of a reference biologic product. An array protein analytical techniques was used compare the physicochemical properties proposed biosimilar filgrastim (EP2006), US-approved originator filgrastim, EU-approved filgrastim. Biological characterization involved surface plasmon resonance spectroscopy analyses in vitro proliferation assays. A randomized, double-blind, two-way crossover, phase I study healthy volunteers assessed pharmacodynamics, pharmacokinetics, safety profiles EP2006 (administered as single subcutaneous 10 µg/kg injection). (US EU approved) were highly with respect primary, secondary, tertiary structures; mass, size, charge, hydrophobicity. No differences receptor binding affinity observed, all samples demonstrated bioactivity. In study, no statistically significant between noted pharmacodynamic or pharmacokinetic parameters, confidence intervals within equivalence boundaries. The two products had profiles. These studies robust evidence structural functional similarity (EP2006)