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

@inproceedings{Soergel2015ComparabilityOB,
  title={Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics},
  author={Fritz Soergel and Arnd Schwebig and Johann Holzmann and Stefan J Prasch and Pritibha Singh and Martina Kinzig},
  booktitle={BioDrugs},
  year={2015}
}
Biosimilars provide safety, purity, and potency similar to those of a reference biologic product. An array of protein analytical techniques was used to compare the physicochemical properties of proposed biosimilar filgrastim (EP2006), US-approved originator filgrastim, and EU-approved originator filgrastim. Biological characterization involved surface plasmon resonance spectroscopy analyses and in vitro proliferation assays. A randomized, double-blind, two-way crossover, phase I study in… CONTINUE READING