BioDrugs

, Volume 30, Issue 2, pp 153–160 | Cite as

Tbo-Filgrastim: A Review in Neutropenic Conditions

Adis Drug Evaluation
First Online:

Abstract

Tbo-filgrastim (filgrastim XM02; Biograstim®, Ratiograstim®, Tevagrastim®) is approved in the EU as a biosimilar of filgrastim (Neupogen®) for use in all indications for which reference filgrastim is approved, including chemotherapy-induced neutropenia, neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation, mobilization of peripheral blood stem cells (PBSCs), severe chronic neutropenia, and neutropenia in HIV infection. Tbo-filgrastim (Granix®) is also approved as a biologic in the USA for neutropenia associated with chemotherapy. Tbo-filgrastim has demonstrated bioequivalence to reference filgrastim in terms of its pharmacokinetic and pharmacodynamic profiles. In phase III trials, tbo-filgrastim was equivalent to reference filgrastim in ameliorating severe neutropenia in patients receiving chemotherapy for breast cancer, lung cancer, or non-Hodgkin lymphoma. In addition, the efficacy of tbo-filgrastim for PBSC mobilization in the allogeneic and autologous settings has been demonstrated in several small studies. Tbo-filgrastim was generally well tolerated, with a similar safety profile to that of reference filgrastim. Most adverse events were of mild or moderate severity. Biosimilars such as tbo-filgrastim have the potential to reduce healthcare costs compared with those of reference filgrastim; this may provide patients with more cost-effective treatment options. Current evidence indicates that tbo-filgrastim is a useful alternative to reference filgrastim in patients requiring filgrastim therapy for various neutropenic conditions.

Keywords

Neutropenia Febrile Neutropenia Absolute Neutrophil Count Autologous Stem Cell Transplantation Filgrastim 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
This is a preview of subscription content, log in to check access.

Notes

Acknowledgments

During the peer review process, the manufacturer of tbo-filgrastim was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Compliance with Ethical Standards

Funding

The preparation of this review was not supported by any external funding.

Conflict of interest

Hannah Blair and Lesley Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

References

  1. 1.
    Crawford J, Armitage J, Balducci L, et al. Myeloid growth factors. J Natl Compr Canc Netw. 2013;11(10):1266–90.PubMedGoogle Scholar
  2. 2.
    Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2015;33(28):3199–212.CrossRefPubMedGoogle Scholar
  3. 3.
    Gascon P. The evolving role of biosimilars in haematology-oncology: a practical perspective. Ther Adv Hematol. 2015;6(6):267–81.CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Teva. Teva announces FDA grants approval for tbo-filgrastim for the treatment of chemotherapy-induced neutropenia [media release]. http://ir.tevapharm.com. 30 Aug 2012.
  5. 5.
    European Medicines Agency. Tevagrastim solution for injection or infusion: summary of product characteristics. 2014. http://www.ema.europa.eu. Accessed 18 Mar 2016.
  6. 6.
    Sicor Biotech. Granix® (tbo-filgrastim) for injection, for subcutaneous use: US prescribing information. 2014. http://www.accessdata.fda.gov. Accessed 18 Mar 2016.
  7. 7.
    Frampton JE, Lee CR, Faulds D. Filgrastim: a review of its pharmacological properties and therapeutic efficacy in neutropenia. Drugs. 1994;48(5):731–60.CrossRefPubMedGoogle Scholar
  8. 8.
    Adar L, Avisar N, Lammerich A, et al. A thorough QT study to assess the effects of tbo-filgrastim on cardiac repolarization in healthy subjects. Drug Des Devel Ther. 2015;9:2653–62.CrossRefPubMedPubMedCentralGoogle Scholar
  9. 9.
    Guneysel O, Onur OE, Denizbasi A. Effects of recombinant human granulocyte colony-stimulating factor (filgrastim) on ECG parameters in neutropenic patients: a single-centre, prospective study. Clin Drug Investig. 2009;29(8):551–5.CrossRefPubMedGoogle Scholar
  10. 10.
    Lubenau H, Bias P, Maly AK, et al. Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trial. BioDrugs. 2009;23(1):43–51.CrossRefPubMedGoogle Scholar
  11. 11.
    Lubenau H, Sveikata A, Gumbrevicius G, et al. Bioequivalence of two recombinant granulocyte colony-stimulating factor products after subcutaneous injection in healthy volunteers. Int J Clin Pharmacol Ther. 2009;47(4):275–82.CrossRefPubMedGoogle Scholar
  12. 12.
    del Giglio A, Eniu A, Ganea-Motan D, et al. XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy. BMC Cancer. 2008;8:332.CrossRefPubMedPubMedCentralGoogle Scholar
  13. 13.
    Gatzemeier U, Ciuleanu T, Dediu M, et al. XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy. J Thorac Oncol. 2009;4(6):736–40.CrossRefPubMedGoogle Scholar
  14. 14.
    Engert A, Griskevicius L, Zyuzgin Y, et al. XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leuk Lymphoma. 2009;50(3):374–9.CrossRefPubMedGoogle Scholar
  15. 15.
    Engert A, del Giglio A, Bias P, et al. Incidence of febrile neutropenia and myelotoxicity of chemotherapy: a meta-analysis of biosimilar G-CSF studies in breast cancer, lung cancer, and non-Hodgkin’s lymphoma. Onkologie. 2009;32(10):599–604.CrossRefPubMedGoogle Scholar
  16. 16.
    Schmitt M, Publicover A, Orchard KH, et al. Biosimilar G-CSF based mobilization of peripheral blood hematopoietic stem cells for autologous and allogeneic stem cell transplantation. Theranostics. 2014;4(3):280–9.CrossRefPubMedPubMedCentralGoogle Scholar
  17. 17.
    Danylesko I, Sareli R, Bloom-Varda N, et al. Biosimilar filgrastim (Tevagrastim, XM02) for allogeneic hematopoietic stem cell mobilization and transplantation in patients with acute myelogenous leukemia/myelodysplastic syndromes. Biol Blood Marrow Transplant. 2015;22(2):277–83.CrossRefPubMedGoogle Scholar
  18. 18.
    Schmitt M, Xu X, Hilgendorf I, et al. Mobilization of PBSC for allogeneic transplantation by the use of the G-CSF biosimilar XM02 in healthy donors. Bone Marrow Transplant. 2013;48(7):922–5.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Shaughnessy PMD, Stevens DBSN, Lavender JRN, et al. Tbo-filgrastim compared to filgrastim for mobilization of hematopoietic stem cells in normal donors [abstract no. 68]. J Clin Apheresis. 2015;30(2):102.Google Scholar
  20. 20.
    Elayan MM, Horowitz JG, Magraner JM, et al. Tbo-filgrastim versus filgrastim during mobilization and neutrophil engraftment for autologous stem cell transplantation. Biol Blood Marrow Transplant. 2015;21(11):1921–5.CrossRefPubMedGoogle Scholar
  21. 21.
    Laszlo D, Andreola G, Babic A, et al. Plerixafor in combination with originator or biosimilar XM02-G-CSF as first-line peripheral blood stem cell mobilisation strategy in patients with lymphomas and multiple myeloma candidate to ASCT: a single-centre experience [abstract no. P709]. Bone Marrow Transplant. 2012;47(Suppl 1):S236–7.Google Scholar
  22. 22.
    Publicover A, Richardson DS, Davies A, et al. Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment. Br J Haematol. 2013;162(1):107–11.CrossRefPubMedGoogle Scholar
  23. 23.
    Shaughnessy P, Elayan M, Stevens D, et al. Filgrastim and plerixafor compared to tbo-filgrastim and plerixafor for mobilization of hematopoietic stem cells for autologous stem cell transplantation [abstract no. 41]. J Clin Apheresis. 2015;30(2):86.Google Scholar
  24. 24.
    Pettengell R, Bias P, Mueller U, et al. Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor. Support Care Cancer. 2016. doi: 10.1007/s00520-015-3057-2.PubMedGoogle Scholar
  25. 25.
    European Medicines Agency. Assessment report for Tevagrastim 2008. http://www.ema.europa.eu. Accessed 18 Mar 2016.
  26. 26.
    Niederwieser D, Schmitz S. Biosimilar agents in oncology/haematology: from approval to practice. Eur J Haematol. 2011;86(4):277–88.CrossRefPubMedPubMedCentralGoogle Scholar
  27. 27.
    Fiala MA, Schwab D, Vij R, et al. A randomized trial of tbo-filgrastim versus filgrastim for autologous stem cell mobilization in patients with multiple myeloma or non-Hodgkin lymphoma [abstract no. 516]. In: 57th American Society of Hematology Annual Meeting & Exposition; 2015.Google Scholar
  28. 28.
    Bennett CL, Chen B, Hermanson T, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol. 2014;15(13):e594–605.CrossRefPubMedPubMedCentralGoogle Scholar
  29. 29.
    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;13(3):478–83.PubMedPubMedCentralGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations