The safety of granulocyte colony-stimulating factor (G-CSF; filgrastim) biosimilars was compared with that of the originator, Neupogen (Amgen), in a retrospective, single-institution study. 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.
Tevagrastrim 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 Tevagrastrim (Filgrastim XM02) (Sandoz) and 39 patients 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.
Filgrastim treatment is used to stimulate the bone marrow to produce neutrophils to fight infection in patients undergoing chemotherapy [2]. The dose administered in this study varied according to the patient’s diagnosis.
Similar safety profile
It has previously been suggested that no major differences in safety should be expected between the originator molecule and biosimilars given the equivalence of biosimilars in terms of pharmacokinetics, pharmacodynamics and mechanism of action [3].
Bassi and co-authors recorded no severe adverse events, and treatment never had to be interrupted during the study period. During post-transplant neutropenia 26 patients developed fever, which lasted a median of 2 days (range, 1‒7 days). Other complications, such as mucositis, were seen mainly because of high-dose chemotherapy. Extra-haematological adverse events that occurred included one episode of atrial fibrillation, heart congestion, flutter, toxic hepatitis and, in three patients, a symptomatic cutaneous rash.
The safety profile in this study did not show specific toxicities related to filgrastim biosimilars. Any adverse events observed were similar to those previously reported with the originator.
The authors conclude that the two filgrastim biosimilars used (Tevagrastim and Zarzio) were safe for facilitating bone marrow recovery in patients with haematological malignancies who underwent autologous HSCT. Prospective studies are now needed to confirm the results of this retrospective study.
The findings fall in line with a growing number of reports concluding that biosimilar G-CSF is as safe and effective in stem cell mobilization as the originator G-CSF [4].
Conflict of interest
The authors of the research paper [1] declared that they had no conflicts of interest.
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References
1. 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.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-filgrastim
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar filgrastim highly similar to originator filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 7]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-filgrastim-highly-similar-to-originator-filgrastim
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar G-CSF safe for mobilization of stem cells [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 7]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-G-CSF-safe-for-mobilization-of-stem-cells
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