Comparison of biosimilar granulocyte colony-stimulating factor (G-CSF), Nivestim and originator G-CSF, Neupogen (filgrastim), showed no statistical differences when used for the mobilization of peripheral blood stem cells in patients treated for haematological malignancies [1].
The results of the retrospective analysis were presented at the 19th Congress of the European Hematology Association (EHA), which was held in Milan, Italy, on 12–15 June 2014.
Filgrastim is a growth factor used to aid the recovery of bone marrow after chemotherapy treatment for cancer. Especially in patients with neutropenia (low white blood cell count in the blood), which causes reduced immune response. It may also be used to mobilize CD34+ peripheral blood stem cells to restore normal haematopoietic function in patients with certain haematologic malignancies.
The 186 patients administered 10 mg/kg of G-CSF included in the study were stratified according to the haematological malignancy they were treated for (acute myeloid leukaemia, multiple myeloma, non-Hodgkin’s lymphoma or Hodgkin’s lymphoma).
In patients treated for acute myeloid leukaemia, the median number of days G-CSF was administered before mobilization was 11.5 for the Neupogen group, and 14 for the Nivestim group (p = 0.892). The median value of CD34+ cells collected was 7.6 x 106/kg for the Neupogen group and 7.0 x 106/kg for the Nivestim group (p = 0.854).
In patients treated for multiple myeloma, the median number of days G-CSF was administered before mobilization was 7 for the Neupogen group and 8 for the Nivestim group (p = 0.064). The median value of CD34+ cells collected was 11.6 x 106/kg for the Neupogen group and 11.9 x 106/kg for the Nivestim group (p = 0.459).
Similar results were also obtained for patients treated for non-Hodgkin’s lymphoma and Hodgkin’s lymphoma.
The authors therefore concluded that ‘since no statistically significant difference was observed in the tested parameters’ the biosimilar G-CSF, Nivestim, ‘was not inferior’ when compared to the originator biological drug Neupogen in peripheral blood stem cell mobilization.
Conflict of interest
The authors of the abstract [1] did not declare any conflicts of interest.
Editor’s comment
It should be noted that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
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Reference
1. Roncevic P, Dreta B, A Ostojić A, et al. A comparative analysis of effectiveness of two granulocyte colony-stimulating factors (GCSF), an original drug Neupogen and a biosimilar Nivestim, in mobilisation of peripheral blood stem cells. Haematologica. 2014;99(s1):720.
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