EMA approved the first biosimilar G-CSF in 2008, and there are currently six biosimilar G-CSF licensed for use in the EU [1].

G-CSF can be used, following autologous stem cell transplantation, to reduce the time to neutrophil recovery and the number of days with fever. In a recent paper, the evidence for the safety and efficacy of G-CSF biosimilars used for this indication is reviewed [2].

In a study of patients recovering from treatment for lymphoma, myeloma or solid tumours, no difference was found between use of brand-name or biosimilar G-CSF to aid neutrophil recovery and reduce the number of days with fever. The clinical parameters evaluated were the number of G-CSF injections, the number of days of hospitalization, the number of units of red blood cell or platelet transfusions, the days on which body temperature exceeded 38°C, the days of parenteral nutrition, the weight loss and the hospitalization costs.

With respect to cost, significant differences (p < 0.00001) were observed, confirming that biosimilars are cheaper than brand-name G-CSF. The author did point out, however, that as part of the total hospitalization this did not make a difference. This was due to the fact that the cost of G-CSF only made up 1% of the total costs of the procedure.

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

Editor’s comment
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References

1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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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