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Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers

Authors
 Chungam Choi  ;  Byung Won Yoo  ;  Choon ok Kim  ;  Taegon Hong  ;  Byung Hak Jin  ;  Kwang-Seok Seo  ;  Ja Yun Jang  ;  Min Soo park 
Citation
 DRUG DESIGN DEVELOPMENT AND THERAPY, Vol.12 : 2381-2387, 2018 
Journal Title
 DRUG DESIGN DEVELOPMENT AND THERAPY 
Issue Date
2018
MeSH
Adult ; Biosimilar Pharmaceuticals/pharmacokinetics* ; Cross-Over Studies ; Filgrastim/adverse effects ; Filgrastim/pharmacokinetics* ; Filgrastim/pharmacology ; Healthy Volunteers ; Humans ; Male ; Middle Aged
Keywords
G-CSF ; bioequivalence ; biologics ; biosimilar
Abstract
Purpose: Filgrastim, a granulocyte-colony stimulating factor, is used to treat patients with neutropenia, including neutropenic fever. Leucostim® is a recombinant filgrastim product tested for biosimilarity with its reference product, Neupogen®. We conducted a comparative clinical trial of the 2 products. Patients and methods: A randomized, open-label, 2-way crossover, single-dose Phase I study was conducted for 56 healthy subjects. After a 5 and 10 μg/kg single subcutaneous administration of test and reference product, pharmacokinetic and pharmacodynamic parameters (absolute neutrophil count and CD34+ cell count) were compared. During the study, safety tests and adverse event monitoring were performed. Results: The test and the reference products had a comparable pharmacokinetic, pharmacodynamic, and safety profile. In both 5 and 10 μg/kg dosing, the 90% CIs of the test to reference ratio for primary parameters (peak plasma concentration and area under the plasma concentration vs time curve from time 0 extrapolated to the infinite time for plasma filgrastim concentration; maximal effect and area under the time-effect curve from time 0 to time of the last quantifiable effect for absolute neutrophil count) were within the 0.8-1.25 range. In addition, safety profiles between the 2 products were similar without any serious adverse events. Conclusion: This study has provided firm clinical evidence that the test filgrastim product is similar to its reference filgrastim product.
Files in This Item:
T201805980.pdf Download
DOI
10.2147/DDDT.S158277
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Choon Ok(김춘옥) ORCID logo https://orcid.org/0000-0002-2319-1108
Yoo, Byung Won(류병원) ORCID logo https://orcid.org/0000-0001-6895-1484
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
Hong, Tae Gon(홍태곤) ORCID logo https://orcid.org/0000-0001-7490-0085
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/169795
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