G-CSF biosimilars to Neupogen and Neualsta – pro
Per Zecchini J1. et al. (2017), “The NCCN Clinical Practice Guidelines has incorporated filgrastim-sndz into its recommendations as a category 1 recommendation for use in settings of febrile neutropenia, myelosuppressive chemotherapy administration, and post-hematopoietic stem cell transplant (HSCT). As a cost-saving initiative, our institution switched from filgrastim to filgrastim-sndz for all indications starting in March 2016. The purpose of this study was to assess for any difference in clinical or safety outcomes between filgrastim and filgrastim-sndz. This is an IRB-approved, single institution, 1-year retrospective chart review (September 2015 to August 2016) conducted in hospitalized adults who received either filgrastim or filgrastim-sndz either for prophylaxis of chemotherapy-induced myelosuppression or for neutrophil recovery after autologous HSCT. Our data showed no differences in duration of G-CSF therapy (7.96 vs. 8.5 days, P = 0.36), white blood count (WBC) (8.99 vs. 8.04, P = 0.28), absolute neutrophil count (ANC) (7.62 vs. 6.91 × 109/L, P = 0.36) at the time of granulocyte-colony stimulating factor (G-CSF) discontinuation, or safety of filgrastim and filgrastim-sndz. The efficacy and safety of filgrastim and filgrastim-sndz were similar for prophylaxis of chemotherapy-induced neutropenia and neutrophil recovery post-autologous HSCT.”
According to Cesaro et al. (2015), “Recently biosimilars of granulocyte-colony-stimulating factor (G-CSF) became available for prophylaxis and treatment of postchemotherapy neutropenia and for mobilization of peripheral blood CD34+ cells for either autologous or allogeneic hematopoietic stem cell transplant.” Cesaro et al. conducted a study and concluded, “Biosimilar G-CSF resulted as effective and safe as originator filgrastim molecule in mobilizing PBSCs in children, with the advantage of a reduced cost.”
Per Bonig, H., Becker, P. S., Schwebig, A., & Turner, M. (2015), “Aggregate clinical evidence supports the assessment by the EMA of biosimilar and originator G-CSF as highly biologically similar, with respect to desired and undesired effects.”
Per Awad et al. (2017), “Neutropenia is a condition that, if left untreated, can result in significant health consequences. With its FDA approval, Zarxio is the first biosimilar to provide an alternative to Neupogen that is similar in safety and efficacy. This allows providers and the market more than one option in treating the various forms of neutropenia at a lower cost.”
LITERATURE:
Awad, M., Singh, P., & Hilas, O. (2017). Zarxio (Filgrastim-sndz): The First Biosimilar Approved by the FDA. Pharmacy and Therapeutics, 42(1), 1923.
Bonig, H., Becker, P. S., Schwebig, A., & Turner, M. (2015). Biosimilar granulocyte-colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?. Transfusion, 55(2), 430439. https://doi.org/10.1111/trf.12770
Cesaro, S., Tridello, G., Prete, A., Dallorso, S., Cannata, E., Massaccesi, E., Risso, M., De Bortoli, M., & Caselli, D. (2015). Biosimilar granulocyte-colony-stimulating factor for mobilization of autologous peripheral blood stem cells in pediatric hematology-oncology patients. Transfusion, 55(2), 246-52
Zecchini J1. et al. (2017). A single-center, retrospective analysis to compare the efficacy and safety of filgrastim-sndz to filgrastim for prophylaxis of chemotherapy-induced neutropenia and for neutrophil recovery following autologous stem cell transplantation. Support Care Cancer. 2018 Mar;26(3):1013-1016. doi: 10.1007/s00520-017-3923-1. Epub 2017 Oct 8.