Pharmacodynamic response of biosimilar filgrastim

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Pharmacodynamic response of biosimilar filgrastim

Biosimilars/Research | Posted 22/04/2011 0 Post your comment

Research published online on 10 March 2011 on the pharmacodynamic response of recombinant human granulocyte colony-stimulating factor (G-CSF) filgrastim has shown that there is no difference between biosimilar and originator G-CSF.

Filgrastim, a growth factor, is used to aid the recovery of bone marrow after chemotherapy treatment for cancer. This is especially significant in patients with neutropenia (low white blood cell count in the blood), which causes reduced immune response.

The pharmacodynamic response, in terms of the mobilisation of CD34+ peripheral blood stem cells, was measured in 40 cancer patients who received Zarzio (biosimilar G-CSF, Sandoz). The data were compared to historical data on patients who received Neupogen (originator G-CSF, Amgen) at the same centre according to the same clinical protocol.

No significant differences were observed between groups in median CD34+ cells mobilised and collected, or the number of G-CSF injections and leukapheresis (separation of white blood cells) required to obtain the minimal CD34+ cell count. The proportion of failures was also similar in both groups.

The results of this study complement those of previous studies carried out by Sandoz, which demonstrated the biosimilarity of Zarzio with the reference product Neupogen. This resulted in approval of Zarzio in the EU in February 2009 for the same indications as Neupogen.

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Development of a new biosimilar filgrastim product (Zarzio)

Reference

Lefrère F, Brignier A, Elie C, et al. First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony-stimulating factor. Adv Ther. 2011. Published online 2011 March 10. doi: 10.1007/s12325-011-0009-1