Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
Institute of Immunology, Oslo University Hospital-Rikshospitalet and Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Bone Marrow Transplant. 2019 Jun;54(6):858-866. doi: 10.1038/s41409-018-0350-y. Epub 2018 Oct 3.
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.
尽管自 2008 年以来，欧洲药品管理局已批准粒细胞集落刺激因子（G-CSF）的生物类似物菲立根，但对于其在相关和不相关的健康造血干细胞供者中的应用仍存在一些争议。我们回顾了已发表的使用生物类似物菲立根进行健康供者动员的经验，以及世界骨髓捐献者协会（WMDA）对其在相关和不相关供者的登记相关移植和采集中心的当前使用情况的调查结果。共有 1287 名健康供者和志愿者被纳入研究。药代动力学和药效动力学研究表明，其与参比产品 Neupogen 具有高度相似性。也发现 CD34+细胞的动员以及报告的不良事件也具有可比性，尽管 Neupogen 和菲立根生物类似物都缺乏长期随访。没有证据表明使用菲立根生物类似物会增加形成菲立根抗体的风险。基于这一经验的增加，WMDA 因此建议干细胞捐献者登记处可以使用菲立根生物类似物来动员健康供者的外周血祖细胞，前提是它们已获得国家和/或地区机构的批准。
