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Current use of biosimilar G-CSF for haematopoietic stem cell mobilisation
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.ORCID iD: 0000-0002-3541-2027
Univ Oslo, Oslo Univ Hosp, Inst Immunol, Rikshosp, Oslo, Norway;Univ Oslo, Inst Clin Med, Oslo, Norway.
Univ Hosp Basel, Dept Hematol, Basel, Switzerland;Univ Basel, Basel, Switzerland.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.ORCID iD: 0000-0002-2101-4183
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2019 (English)In: Bone Marrow Transplantation, ISSN 0268-3369, E-ISSN 1476-5365, Vol. 54, no 6, p. 858-866Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
NATURE PUBLISHING GROUP , 2019. Vol. 54, no 6, p. 858-866
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Hematology
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URN: urn:nbn:se:uu:diva-387921DOI: 10.1038/s41409-018-0350-yISI: 000470103100009PubMedID: 30283148OAI: oai:DiVA.org:uu-387921DiVA, id: diva2:1331210
Note

The Working Group Medical of the World Marrow Donor Association

Available from: 2019-06-26 Created: 2019-06-26 Last updated: 2019-06-26Bibliographically approved

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Pahnke, SimonHägglund, Hans

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