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

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 experience...

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Bibliographic Details
Published in:Bone marrow transplantation (Basingstoke) 2019-06, Vol.54 (6), p.858-866
Main Authors: Pahnke, Simon, Egeland, Torstein, Halter, Jörg, Hägglund, Hans, Shaw, Bronwen E, Woolfrey, Ann E, Szer, Jeff
Format: Article
Language:English
Subjects:
692/308/2171
692/700/565/2194
692/700/565/2319
Antibodies
CD34 antigen
Cell Biology
Colony-stimulating factor
Granulocyte colony-stimulating factor
Hematology
Hematopoietic stem cells
Hemopoiesis
Internal Medicine
Leukocytes (granulocytic)
Medicine
Medicine & Public Health
Peripheral blood
Pharmacodynamics
Pharmacokinetics
Pharmacology
Progenitor cells
Public Health
Stem cell transplantation
Stem Cells
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Summary: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.
ISSN:0268-3369
1476-5365
1476-5365
DOI:10.1038/s41409-018-0350-y