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.

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Author information


  1. Department of Medical Sciences, Uppsala University, Uppsala, Sweden

    • Simon Pahnke
    •  & Hans Hägglund
  2. Institute of Immunology, Oslo University Hospital—Rikshospitalet and Institute of Clinical Medicine, University of Oslo, Oslo, Norway

    • Torstein Egeland
  3. Department of Hematology, University Hospital Basel and University of Basel, Basel, Switzerland

    • Jörg Halter
  4. Centre for International Blood and Bone Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, Wisconsin, USA

    • Bronwen E Shaw
  5. Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA

    • Ann E Woolfrey
  6. Department of Medicine, University of Washington, Seattle, Washington, USA

    • Ann E Woolfrey
  7. Integrated Haematology Department, Victorian Comprehensive Cancer Centre, Royal Melbourne Hospital, Melbourne, Victoria, Australia

    • Jeff Szer


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  1. on behalf of the Working Group Medical of the World Marrow Donor Association

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    Correspondence to Simon Pahnke.

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