A clinical comparison of the efficacy and safety of biosimilar G-CSF and originator G-CSF in haematopoietic stem cell mobilization

Background: recombinant granulocyte colony-stimulating factor (g-csf) is widely used to mobilize haematopoietic stem cells. we compared the efficacy and safety of a biosimilar g-csf (zarzio®,sandoz biopharmaceuticals) with the originator g-csf (neupogen®,amgen) in patients with haematological malignancies. methods: a total of 108 patients were included in this study,59 of whom were female (49male),with an overall median age of 51 years (range 19-69). patients had multiple myeloma (n = 46),non-hodgkin's lymphoma (n = 28),hodgkin's lymphoma (n = 26),or other diagnosis (n = 8). after administration of mobilizing regimens (primarily high-dose etoposide,high-dose cyclophosphamide,intermediate-dose ara-c or eshap),patients were randomized to a standard daily 10 μg/kg dose of biosimilar g-csf (n = 54) or originator g-csf (n = 54). results: median duration of g-csf administration was 8 days with both biosimilar g-csf (range 4-17) and originator g-csf (range 4-14). both groups had a median of one apheresis with a median time until first apheresis of 11 days. there were no statistically significant differences between groups in the mean ± sd number of mobilized cd34+ cells/ml in peripheral blood or the number of cd34+ cells/kg body weight. five patients (9%) in the originator g-csf group and six patients in the biosimilar g-csf group (11%) did not mobilize sufficient cd34+ cells. the adverse event profile was similar between groups. conclusions: a biosimilar g-csf (zarzio®) demonstrated similar efficacy and safety as the reference originator g-csf (neupogen®) in hematopoietic stem cell mobilization in patients with haematological malignancies. - 2014 institute of pharmacology,polish academy of sciences. published by elsevier urban & partner sp. z o.o. all rights reserved.