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Updated: Jun 17, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Development of a new G-CSF product based on biosimilarity assessment
1Division of Medical Oncology, Hospital Clinic, Barcelona University, Barcelona, Spain.
Zarzio, a biosimilar filgrastim, demonstrated comparable pharmacokinetics and pharmacodynamics to Neupogen in healthy volunteers. Clinical studies confirmed Zarzio
Area of Science:
- Pharmacology
- Biotechnology
- Oncology
Background:
- Zarzio is a novel recombinant human granulocyte colony-stimulating factor (filgrastim).
- Evaluation of Zarzio involved phase I and III clinical studies in healthy volunteers and neutropenic patients.
Purpose of the Study:
- To assess the pharmacokinetic and pharmacodynamic comparability of Zarzio to its reference product, Neupogen.
- To evaluate the efficacy and safety of Zarzio in breast cancer patients undergoing chemotherapy.
Main Methods:
- Randomized crossover studies in healthy volunteers comparing single and multiple doses of Zarzio and Neupogen.
- Pharmacokinetic (serum levels) and pharmacodynamic (neutrophil and CD34+ cell counts) parameters were monitored.
- Phase III study involved 170 breast cancer patients receiving Zarzio for neutropenia prophylaxis during chemotherapy.
Main Results:
- Pharmacokinetic and pharmacodynamic results in healthy volunteers confirmed Zarzio's comparability to Neupogen.
- Equivalence boundaries for confidence intervals were met.
- Zarzio demonstrated efficacy and safety in breast cancer patients, with no observed immunogenicity.
Conclusions:
- Zarzio is biosimilar to the reference product, Neupogen.
- The studies support Zarzio's use as a safe and effective filgrastim biosimilar.
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