Premium
A comparative pharmacokinetic and pharmacodynamic study of FSK0808 versus reference filgrastim after repeated subcutaneous administration in healthy Japanese men
Author(s) -
Matsuguma Kyoko,
Matsuki Shunji,
Sakamoto Kei,
Shiramoto Masanari,
Nakagawa Misato,
Kimura Miyuki,
Irie Shin,
Kaneko Daiki,
Ohnishi Akihiro
Publication year - 2015
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.178
Subject(s) - filgrastim , cmax , medicine , pharmacokinetics , pharmacodynamics , biosimilar , pharmacology , crossover study , granulocyte colony stimulating factor , confidence interval , area under the curve , absolute neutrophil count , toxicity , chemotherapy , neutropenia , placebo , alternative medicine , pathology
FSK0808, a biosimilar of filgrastim, is a recombinant human granulocyte colony‐stimulating factor developed by Fuji Pharmaceuticals and Mochida Pharmaceutical Co., Ltd. We conducted a double‐blind, randomized, crossover study in healthy Japanese men, comparing the number of CD34‐positive cells (CD34 + cells) after repeated subcutaneous administration of either FSK0808 or the reference filgrastim (Gran ® ). As primary endpoints, we compared the maximum number of CD34 + cells (CD34 + C max ) and the time to reach CD34 + C max (CD34 + t max ). As secondary endpoints, we compared the area under the curve for the number of CD34 + cells over time at the 410 hours time point (CD34 + AUC 0–410 ), the parameters used to calculate the pharmacodynamic index of the absolute neutrophil count, and the pharmacokinetic parameters. Regarding the CD34 + C max and the CD34 + AUC 0–410 values, the 95% confidence interval (CI) of the differences between the mean values for each drug was within the range of log(0.8)–log(1.25). With respect to the differences in the median values between drugs, the ratio against the reference filgrastim median value in the 95% CI was within the range of ± 0.2 for the CD34 + t max value. From these results, we considered that these drugs display equivalent pharmacodynamic and pharmacokinetic properties.