The evaluation of the efficacy and safety of original filgrastim (neupogen ®) , biosimilar filgrastim (leucostim®) and lenograstim (granocyte ® ) in CD34+ peripheral hematopoietic stem cell mobilisation procedures for allogeneic hematopoieitic stem cell transplant donors

Abstract Objectives and aim In this study, we aimed to compare the potency of different G-CSF agents including original filgrastim (Neupogen®), biosimilar filgrastim (Leucostim®) and Lenograstim (Granocyte®) on CD34+ cell mobilisation in patients that underwent allogeneic hematopoieitic stem cell transplantation (alloHSCT). Patients and Methods The data of 243 donors for alloHSCT recipients diagnosed with mostly acute lekemia and myelodsyplastic syndromes (MDS) were analysed, retrospectively. Data for stem cell mobilisation has been recorded from patients' files. Donors who received Filgrastim (Neupogen®, Group I), biosimilar Filgrastim (Leucostim®, Group II) and Lenograstim (Granocyte®, Group III) were analysed for total CD34+ cell count at the end of mobilisation procedures. Results A total of 243 donors and patients for alloHSCT were analyzed retrospectively. The diagnosis of the patients were; acute myeloid leukemia (AML) (110 patients, 45.2%), acute lymphoid leukemia (ALL) (61 patients, 25.1%), aplastic anemia (AA) (38 patients, 15.6%), lymphomas (14 patients, 5.7%) and others (20 patients, 8.4%). The median number of total collected PB CD34+ cells (x106 /kg) was 7.12 (min-max:5.38-7.90) in the Neupogen® group, 7.27 (min-max:6.79-7.55) in the Leucostim® group and 7.15 (min-max:5.34-7.58) in the Granocyte® group. There was no statistically significant difference among groups in term of total collected PB CD34+ cells (p=0.919). The median doses of G-CSF agents (µg/kg/day) in PBSC collection in Neupogen® group was; 11.00 (10.00-12.00 ) in Leucostim® group10.35 (min-max: 10.00-11.10) and in Granocyte® group11.00 (min-max: 10.00-11.00). There was no statistical significance among groups (p=0.215). Conclusion Biosimilar filgrastim (Leucostim®) was found comparable to original Filgrastim (Neupogen®) and Lenograstim (Granocyte®) for PBSC mobilization in donors of the patients that underwent alloHSCT.