The efficacy of granulocyte colony-stimulating factor (G-CSF; filgrastim) biosimilars has been assessed in terms of engraftment following stem-cell transplantation. Time to engraftment was compared following treatment with the originator, Neupogen (Amgen), and with biosimilars in a retrospective, single-institution study.
During engraftment, transplanted stem cells enter the bloodstream, migrate to the bone marrow and start producing new neutrophils and platelets. Engraftment occurs on average 10 days to four weeks after a stem cell transplant. Filgrastim treatment is used to stimulate the bone marrow to produce neutrophils to fight infection in patients undergoing chemotherapy [1].
Simona Bassi and co-authors at the Guglielmo da Saliceto Hospital in Piacenza, Italy, analysed data from patients with lymphoma or myeloma who had undergone autologous haematopoietic stem cell transplantation (HSCT) at the Guglielmo da Saliceto Hospital [2]. The authors compared their results with recently published data on the originator.
Tevagrastim and Zarzio
Data from 56 patients treated between 2011 and 2014 were included in the study. A total of 25 patients had non-Hodgkin’s lymphoma, 25 patients had multiple myeloma, and 6 patients had Hodgkin’s disease. Of these, 17 patients received Tevagrastim (Filgrastim XM02) (Sandoz), and 39 patients received received Zarzio (Teva) [1]. Although patients were administered different filgrastim biosimilars, the authors present the combined data because no difference was observed in the analysis of the two subgroups. Standard doses were given to patients according to each patient’s diagnosis.
Comparable efficacy
The median number of infused haematopoietic (CD34+) cells was 4.05×106/kg (range, 2.2-7.76×106/kg). The median time to achieve neutrophil recovery was 10 days (range, 8‒11 days) from peripheral blood stem cell infusion, while that for platelet engraftment was 12 days (range, 8‒23 days). Biosimilar filgrastim was administered for a median of 7 days (range, 4-9 days) before leucocyte engraftment.
The authors report that filgrastim biosimilars were effective in the setting of autologous transplant engraftment compared with the originator. In the retrospective study all patients engrafted, except for one who died before bone marrow recovery, and only one patient failed to achieve platelet recovery in refractory disease.
Despite the limitations of being derived from a retrospective and relatively small study, the authors concluded that their efficacy results with filgrastim biosimilars ‘are comparable to those published in the literature’. The authors call for prospective studies to confirm their study results.
Conflict of interest
The authors of the research paper [2] declared that they had no conflicts of interest.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars could save US$44.2 billion over 10 years [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jul 31]. Available from: www.gabionline.net/Reports/Biosimilars-could-save-US-44.2-billion-over-10-years
2. Bassi S, Stroppa EM, Moroni CF, et al. Safety and efficacy of granulocyte colony-stimulating factor biosimilars in engraftment after autologous stem cell transplantation for haematological malignancies: a 4-year, single institute experience with different conditioning regimens. Blood Transfus. 2015 Feb 2:1-6.
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