Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation View Full Text


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Article Info

DATE

2018-10-03

AUTHORS

Simon Pahnke, Torstein Egeland, Jörg Halter, Hans Hägglund, Bronwen E Shaw, Ann E Woolfrey, Jeff Szer

ABSTRACT

Despite biosimilars of the granulocyte-colony stimulating factor (G-CSF) filgrastim being approved by the European Medicines Agency since 2008, there is still some debate regarding their use in related and unrelated healthy haematopoietic stem cell donors. We present a review of published experiences using biosimilar filgrastim for healthy donor mobilisation as well as the results of a survey by the World Marrow Donor Association (WMDA) of its current use by register-associated transplant and collection centres for both related and unrelated donors. A total of 1287 healthy donors and volunteers are included in the reviewed studies. The pharmacokinetics and pharmacodynamics studies show a high degree of similarity to the reference product Neupogen. Mobilisation of CD34 + cells as well as reported adverse events are also found to be comparable, although there is still a lack of long-term follow up for both Neupogen and filgrastim biosimilars. No evidence is found of a higher risk of filgrastim antibody formation using filgrastim biosimilars. Based on this increased experience, the WMDA therefore recommend that Stem Cell Donor Registries can use filgrastim biosimilars for the mobilisation of peripheral blood progenitor cells in healthy donors, provided that they are approved by national and/or regional agencies. More... »

PAGES

1-9

References to SciGraph publications

  • 2014-04. Peripheral Blood Stem Cell Mobilization and Engraftment after Autologous Stem Cell Transplantation with Biosimilar rhG-CSF in ADVANCES IN THERAPY
  • 2014-07. Unrelated adult stem cell donor medical suitability: recommendations from the World Marrow Donor Association Clinical Working Group Committee in BONE MARROW TRANSPLANTATION
  • 2013-07. Mobilization of PBSC for allogeneic transplantation by the use of the G-CSF biosimilar XM02 in healthy donors in BONE MARROW TRANSPLANTATION
  • 2017-10. Biosimilar G-CSF versus filgrastim and lenograstim in healthy unrelated volunteer hematopoietic stem cell donors in ANNALS OF HEMATOLOGY
  • 2014-12. Preclinical and clinical phase I studies of a new recombinant Filgrastim (BK0023) in comparison with Neupogen® in BMC PHARMACOLOGY AND TOXICOLOGY
  • 2010-10. Comparison of the pharmacodynamic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial in ANNALS OF HEMATOLOGY
  • 2011-04. First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony- stimulating factor in ADVANCES IN THERAPY
  • 2010-09. Pharmacokinetic profiles of a biosimilar filgrastim and Amgen filgrastim: results from a randomized, phase I trial in ANNALS OF HEMATOLOGY
  • 2009-02. Pharmacokinetic and Pharmacodynamic Profile of New Biosimilar Filgrastim XM02 Equivalent to Marketed Filgrastim Neupogen® in BIODRUGS
  • 2015-04. Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics in BIODRUGS
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/s41409-018-0350-y

    DOI

    http://dx.doi.org/10.1038/s41409-018-0350-y

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1107377818

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30283148


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