Comparison of biosimilar filgrastim with a reference product: pharmacokinetics, pharmacodynamics, and safety profiles in healthy volunteers
| Autor: | Kwang-Seok Seo, Byung Won Yoo, Taegon Hong, Min Soo Park, Byung Hak Jin, Chungam Choi, Choon Ok Kim, Ja Yun Jang |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Filgrastim Pharmaceutical Science G-CSF Bioequivalence Neutropenia Pharmacology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Pharmacokinetics Drug Discovery medicine Humans biologics Adverse effect Biosimilar Pharmaceuticals bioequivalence Drug Design Development and Therapy Cross-Over Studies business.industry Biosimilar Middle Aged medicine.disease Healthy Volunteers Clinical Trial Report 030220 oncology & carcinogenesis Pharmacodynamics Absolute neutrophil count biosimilar business medicine.drug |
| Zdroj: | Drug Design, Development and Therapy |
| ISSN: | 1177-8881 |
| Popis: | Chungam Choi,1 Byung Won Yoo,2 Choon Ok Kim,2 Taegon Hong,2 Byung Hak Jin,2 Kwang-Seok Seo,3 Ja Yun Jang,4 Min Soo Park2 1Department of Nuclear Medicine, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea; 2Department of Clinical Pharmacology, Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea; 3Biopharmaceutical Research Laboratories, Dong-A Socio R&D Center, Yongin-si, Republic of Korea; 4Product Development Division, Dong-A ST Co., Ltd, Seoul, Republic of Korea 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 PhaseI study was conducted for 56 healthy subjects. After a 5 and 10μg/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 10μg/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. Keywords: bioequivalence, biosimilar, G-CSF, biologics |
| Databáze: | OpenAIRE |
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