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Ongoing monitoring of biosimilar G-CSF (filgrastim)

Biosimilars/Research | Posted 25/03/2011 0 Post your comment

Sandoz is carrying out ongoing studies to ensure the safety of its biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim G-CSF). The MONITOR-GCSF study will recruit at least 1,000 patients from a minimum of 75 centres and follow them for a maximum of six cycles of chemotherapy.

Filgrastim, a growth factor, is 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), causing reduced host defence.

Zarzio, Sandoz’s biosimilar G-CSF product demonstrated in previous clinical trials biosimilarity with the reference product Neupogen (Amgen). This resulted in approval of Zarzio in the EU in February 2009 for the same indications as Neupogen.

The MONITOR-GCSF study is an international, prospective, observational, pharmaco-epidemiological study; which will evaluate the multi-level factors and outcomes associated with the use of Zarzio in the treatment of febrile neutropenia in chemotherapy-treated cancer patients.

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Reference

Gascón P, Aapro M, Ludwig H, et al. Background and methodology of MONITOR-GCSF, a pharmaco-epidemiological study of the multi-level determinants, predictors, and clinical outcomes of febrile neutropenia prophylaxis with biosimilar granulocyte-colony stimulating factor filgrastim. Crit Rev Oncol Hematol. 2011;77(3):184-97.