A Comparative Pharmacokinetic and Pharmacodynamic Study of FSK0808 versus Reference Filgrastim after Repeated Subcutaneous Administration in Healthy Japanese Men

作者：Matsuguma Kyoko; Matsuki Shunji; Sakamoto Kei; Shiramoto Masanari; Nakagawa Misato; Kimura Miyuki; Irie Shin; Kaneko Daiki^*; Ohnishi Akihiro

来源：Clinical Pharmacology in Drug Development, 2015, 4(2): 99-104.

DOI：10.1002/cpdd.178

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 (R)). 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.

• 出版日期2015-4