Abstract
A retrospective cohort study was conducted in Singapore General Hospital to study the safety and efficacy of biosimilar granulocyte-colony stimulating factor (G-CSF) Nivestim for chemo-mobilization of stem cells for autologous stem cell transplant (autoSCT). All patients who underwent an autoSCT between January 2011 and December 2016 were screened for eligibility. A total of 194 patients were screened, and 131 were included. Nivestim was used in 65 patients and the originator G-CSF (Neupogen) in 66. Patient characteristics were similar between both arms except for chemo-mobilization regimen used (p < 0.0001). Mobilization success rates were found to be comparable, at 96.9% (Nivestim) and 97% (Neupogen). Adverse events rates were also similar. Median duration of G-CSF use and hospitalization were both found to be shorter in the Nivestim arm. Median drug acquisition cost per mobilization cycle was significantly lower in the Nivestim arm at $533.40 (range $213.40–$1280.20) as compared to $1261.90 (range $574–$2755.20) in the Neupogen arm (p < 0.0001). No difference was observed for neutrophil and platelet engraftment after autoSCT. Nivestim was found to be safe and non-inferior to Neupogen for chemo-mobilization of stem cells for autoSCT, and associated with lower cost and shorter length of hospitalization.
Highlights
Mobilization of peripheral blood stem cells (PBSCs) upon achieving remission after induction chemotherapy constitutes a critical component in the continuum of an autologous stem cell transplant (autoSCT)
In a meta-analysis of three large randomized, two-arm study for the management of chemotherapy-related neutropenia in non-Hodgkin’s lymphoma, breast and lung cancers, biosimilar granulocyte-colony stimulating factor (G-CSF) were found to be comparable to Neupogen[9]
Based on the available data, biosimilar G-CSFs were approved by the European Medicines Agency (EMA) in 2010 for the same indications as Neupogen based on comparable efficacy, quality and safety[10,15]
Summary
Mobilization of peripheral blood stem cells (PBSCs) upon achieving remission after induction chemotherapy constitutes a critical component in the continuum of an autoSCT. A biosimilar is a biological agent that is comparable in terms of quality, safety and efficacy to the approved original biological medicine[11,12]. Based on the available data, biosimilar G-CSFs were approved by the European Medicines Agency (EMA) in 2010 for the same indications as Neupogen based on comparable efficacy, quality and safety[10,15]. With limited evidence on the effect of Nivestim for mobilization of stem cells and resultant recovery from an autoSCT, this study aimed to compare the efficacy and safety of biosimilar G-CSF (Nivestim) with originator G-CSF (Neupogen) in the context of chemo-mobilization
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