Efficacy and Safety of Biosimilar Filgrastim for Cord Blood Transplantation: A Single-Institution Retrospective Analysis

Abstract

BackgroundFilgrastim has been widely used for hematopoietic recovery after hematopoietic stem cell transplantation. Recently, biosimilar filgrastim (BF) has been approved for the same indications as for the originator filgrastim (OF). However, evidence of the efficacy and safety of BF for unrelated cord blood transplant (CBT) is unreported. Therefore, we evaluated the efficacy and safety of BF and OF (historical control) for CBT. MethodsTwenty-two consecutive patients with hematologic malignant tumors were assessed. Patients received BF (n = 12) or OF (n = 10) from day 1 after CBT for hematopoietic recovery. The time to hematopoietic recovery, total filgrastim dose, duration of filgrastim administration, total transfusion units, incidences of engraftment, documented infection, febrile neutropenia, acute and chronic graft-vs-host disease, incidence and severity of adverse events, hospitalization duration, and 100-day and 1-year overall survival were evaluated. ResultsThe median total dose of BF and OF used for hematopoietic recovery were 9.68 and 10.80 mg, respectively. There were no significant between-group differences in time to hematopoietic recovery, total filgrastim dose, duration of filgrastim administration, total transfusion units, incidences of engraftment, documented infection, febrile neutropenia, acute and chronic graft-vs-host disease, incidence and severity of adverse events, hospitalization duration, and overall survival. Multivariate analysis demonstrated that filgrastim type was not a significant factor for neutrophil recovery. Median total filgrastim costs per patient were 446,405 and 910,320 yen for BF and OF, respectively. ConclusionsBF is as safe and effective as OF for hematopoietic recovery after CBT. BF is a useful option for CBT owing to its economic benefits.