Abstract
The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report the comparison of a biosimilar G-CSF (Zarzio) with two original G-CSFs (filgrastim and lenograstim) in mobilization in unrelated donors. We included data of 313 consecutive donors who were mobilized during the period from October 2014 to March 2016 at the Medical University of Warsaw. The primary endpoints of this study were the efficiency of CD34+ cell mobilization to the circulation and results of the first apheresis. The mean daily dose of G-CSF was 9.1 μg/kg for lenograstim, 9.8 μg/kg for biosimilar filgrastim, and 9.3 μg/kg for filgrastim (p < 0.001). The mean CD34+ cell number per microliter in the blood before the first apheresis was 111 for lenograstim, 119 for biosimilar filgrastim, and 124 for filgrastim (p = 0.354); the mean difference was even less significant when comparing CD34+ number per dose of G-CSF per kilogram (p = 0.787). Target doses of CD34+ cells were reached with one apheresis in 87% donors mobilized with lenograstim and in 93% donors mobilized with original and biosimilar filgrastim (p = 0.005). The mobilized apheresis outcomes (mean number of CD34+ cells/kg of donor collected during the first apheresis) was similar with lenograstim, biosimilar filgrastim, and filgrastim: 6.2 × 106, 7.6 × 106, and 7.3 × 106, respectively, p = 0.06. There was no mobilization failure in any of the donors. Biosimilar G-CSF is as effective in the mobilization of hematopoietic stem cells in unrelated donors as original G-CSFs. Small and clinically irrelevant differences seen in the study can be attributed to differences in G-CSF dose and collection-related factors. Active safety surveillance concurrent to clinical use and reporting to donor outcome registry (e.g., EBMT donor outcome registry or WMDA SEAR/SPEAR) might help to evaluate the possible short- and long-term complications of biosimilar G-CSF.
Highlights
There are over 27 million registered unrelated hematopoietic stem cell donors worldwide, as reported by the World Marrow Donor Association (WMDA) [1]
All three groups had similar demographic data regarding sex distribution and median age; the group mobilized with biosimilar granulocyte-colony stimulating factor (GCSF) had higher body mass (+11% when compared to the median weight in two other groups of patients, p = 0.02), and the group mobilized with filgrastim had higher body mass index than the other two groups, 25.6 vs 24.5 and 24.2 (p = 0.018) (Table 1)
The total mean dosage of granulocyte-colony stimulating factors (G-CSF) to the first apheresis was different in all groups: 40.7 μg/kg for lenograstim (29.0–52.4), 44 μg/kg for biosimilar filgrastim (36–60), and 42 μg/kg for filgrastim (33–55)—the donors who were mobilized with biosimilar filgrastim received mean higher total doses of G-CSF (p = 0.014 vs filgrastim, p < 0.001 vs lenograstim)
Summary
There are over 27 million registered unrelated hematopoietic stem cell donors worldwide, as reported by the World Marrow Donor Association (WMDA) [1]. The standard protocol of mobilization in hematopoietic stem cell donors relies on two original granulocyte-colony stimulating factors (G-CSF): filgrastim and lenograstim. Those drugs have been evaluated in clinical trials and neither showed advantages over another [2]. The experience with mobilization in unrelated stem cell donors using biosimilar GCSF is very limited [7, 8]. The WMDA and the European Society for Blood and Marrow Transplantation both argue against the use of biosimilar G-CSF [9]. The Working Party on Similar Biological (Biosimilar) Medicinal Products of the European Medicines Agency
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