Use of G-CSF biosimilars for stem cell mobilization in autologous transplantation

Biosimilars/Research | Posted 07/06/2013 post-comment0 Post your comment

The first biosimilar granulocyte colony-stimulating factor (G-CSF) was licensed by EMA in 2008, and there are currently six biosimilar G-CSF products licensed for use in the EU [1]. All of these biosimilars are also approved for haematopoietic stem cell transplantation.

Autologous Stem Cell Transplant V13F07

G-CSF can be used to mobilize peripheral blood stem cells (PBSCs) in patients undergoing autologous stem cell transplantation. In this procedure stem cells are removed, stored, and later given back to the same person. In a recent paper the evidence for the safety and efficacy of G-CSF biosimilars used for this indication is reviewed [2].

In a preliminary report comparing brand-name G-CSF and biosimilar G-CSF (Ratiograstim) similar results for days for collection and CD34+ yield were observed. A study comparing brand-name G-CSF (Neupogen) and biosimilar G‑CSF (Zarzio) observed no significant differences between the two groups of patients for CD34+ cells mobilized and collected. While another study evaluating the use of plerixafor, to increase the rate of mobilization, in combination with biosimilar G-CSF was safe and effective.

The author found that the evidence ‘was encouraging for the use of biosimilars for stem cell mobilization in the autologous setting’, however, advocated caution with respect to immunogenicity ‘because of the reported flares of the disease during the mobilization procedure’.

Conflict of interest
The author of the research paper did not declare any conflict of interest.

Editor’s comment
If you are interested in contributing a research paper in biosimilar safety and immunogenicity aspects in GaBI Journal, please send us your submission here.

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1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from:

2.  Bosi A. Use of biosimilars in hematopoietic stem cells transplantation. Drugs and Cell Therapies in Hematology. 2013;2(1):21-6.

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