Pharmacokinetics and pharmacodynamics of FSK0808 and Gran after single intravenous drip administration or single subcutaneous administration: comparative study in healthy Japanese adult male subjects

Abstract FSK0808 is a recombinant human granulocyte colony-stimulating factor developed by Fuji Pharma Co., Ltd and Mochida Pharmaceutical Co., Ltd. as a biosimilar product of Gran®. We verified the pharmacokinetic/pharmacodynamic equivalence of FSK0808 and commercially available Gran® by a randomiz...

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Published in:	Drug development and industrial pharmacy Vol. 41; no. 3; pp. 470 - 475
Main Authors:	Matsuguma, Kyoko, Matsuki, Shunji, Eunhee, Chung, Watanabe, Akimasa, Tanaka, Asuka, Sakamoto, Kei, Takeshita, Hiromi, Hitaka, Akiko, Shigetome, Kyoko, Kimura, Miyuki, Miyamoto, Akiko, Irie, Shin, Kaneko, Daiki, Ohnishi, Akihiro
Format:	Journal Article
Language:	English
Published:	England Informa Healthcare USA, Inc 01-03-2015 Informa Healthcare
Subjects:	Adult Asian Continental Ancestry Group Biosimilar Biosimilar Pharmaceuticals - administration & dosage Biosimilar Pharmaceuticals - pharmacokinetics clinical trial Cross-Over Studies Double-Blind Method filgrastim G-CSF Granulocyte Colony-Stimulating Factor - administration & dosage Granulocyte Colony-Stimulating Factor - pharmacokinetics Healthy Volunteers Humans Infusions, Intravenous Injections, Subcutaneous Male pharmacodynamics pharmacokinetics Young Adult clinical trial filgrastim pharmacokinetics G-CSF pharmacodynamics Biosimilar
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Summary:	Abstract FSK0808 is a recombinant human granulocyte colony-stimulating factor developed by Fuji Pharma Co., Ltd and Mochida Pharmaceutical Co., Ltd. as a biosimilar product of Gran®. We verified the pharmacokinetic/pharmacodynamic equivalence of FSK0808 and commercially available Gran® by a randomized crossover study of single intravenous dose (200 µg/m2) and single subcutaneous dose (400 µg/m2) in healthy Japanese adult male subjects. According to the bioequivalence guidelines, the area under the blood concentration - time curve by 48 hours after administration (AUC0-48) in a single intravenous drip (IVD) study, and AUC0-48 and maximum blood concentration (Cmax) in a single subcutaneous (SC) dose study were used as primary endpoints, and the pharmacodynamic parameters including absolute neutrophil count (ANC) or number of CD34 positive cells (CD34+ cells) as secondary endpoints. The safety was evaluated based on the characteristics and incidence of adverse reactions. As a result, the 90% confidence interval (CI) of the difference in mean value for AUC0-48 among drugs ranged from log(0.8) to log(1.25), in the IVD study, and those for Cmax and AUC0-48 were within the range of log(0.8)-log(1.25) in the SC study. Those for secondary endpoints were all within the range of log(0.8)-log(1.25). Thus, the pharmacokinetics/pharmacodynamics of both drugs were considered equivalent for all routes of administration, and the profiles of adverse reactions were also very similar.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	0363-9045 1520-5762
DOI:	10.3109/03639045.2013.879721