Evaluation of a biosimilar granulocyte colony-stimulating factor (filgrastim XM02) for peripheral blood stem cell mobilization and transplantation: a single center experience in Japan.
BACKGROUND
Biosimilar granulocyte colony-stimulating factor (G-CSF) has recently been introduced into clinical practice. G-CSFs are used to mobilize CD34+cells and accelerate engraftment after transplantation. However, in Asia, particularly in Japan, data for peripheral blood stem cell (PBSC) mobilization by this biosimilar G-CSF are currently lacking. Therefore, the clinical efficacy and safety of biosimilar G-CSF for hematopoietic stem cell transplantation needs to be evaluated in a Japanese context.


METHODS
The subjects included two groups of patients with malignant lymphoma and multiple myeloma. All patients received chemotherapy priming for the mobilization of PBSCs. All patients were treated with chemotherapy followed by the administration of either the biosimilar G-CSF, filgrastim XM02 (FBNK), or the originators, filgrastim, or lenograstim.


RESULTS
There were no significant differences among FBNK, filgrastim, and lenograstim treatments in the numbers of CD34+cells in harvested PBSCs, the scores for granulocyte/macrophage colony forming units, or for malignant lymphoma and multiple myeloma patients evaluated as separate or combined cohorts. In addition, there were no significant differences in safety, side effects, complications, or the time to engraftment after autologous hematopoietic stem cell transplantation.


CONCLUSIONS
Biosimilar FBNK shows the same efficacy and safety as originator G-CSFs for facilitating bone marrow recovery in Japanese malignant lymphoma and multiple myeloma patients undergoing stem cell transplantation. In addition, it is less expensive than the originators, reducing hospitalization costs.
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Hideaki
H
Yoshimura
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Masaaki
M
Hotta
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Takahisa
T
Nakanishi
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Shinya
S
Fujita
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Aya
A
Nakaya
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Atsushi
A
Satake
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Tomoki
T
Ito
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Kazuyoshi
K
Ishii
First Department of Internal Medicine, Kansai Medical University, Hirakata, Osaka, Japan.
Shosaku
S
Nomura
G-CSF; autologous hematopoietic stem cell transplantation; biosimilar; hematological malignancy; peripheral blood stem cell