Filgrastim biosimilar (EP2006) : a review of 15 years’ post-approval evidence
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Date
Authors
Gascón, Pere
Harbeck, Nadia
Rapoport, Bernardo Leon
Anderson, Ronald
Brueckmann, Ines
Howe, Sebastian
Aapro, Matti
Journal Title
Journal ISSN
Volume Title
Publisher
Elsevier
Abstract
Filgrastim is approved for several indications, including reduction of the incidence and duration of chemotherapy-induced neutropenia and for stem cell mobilization. The filgrastim biosimilar, EP2006, has been available in Europe since 2009, and in the United States since 2015. In this time, preclinical and clinical data used to support the approval of EP2006 have been published. These data established the biosimilarity of EP2006 to reference filgrastim in terms of structure, pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity. Additional real-world evidence studies have also demonstrated equivalent efficacy and safety of EP2006 compared with reference filgrastim, both in the reduction of neutropenia and in stem cell mobilization in clinical practice. This review summarizes these preclinical, clinical, and real-world data, as well as the available cost-effectiveness data, for EP2006 since its approval 15 years ago.
Description
Keywords
Cost-effectiveness, Hematopoietic stem cell mobilization, Febrile neutropenia, Chemotherapy-induced neutropenia, Filgrastim, Biosimilar, SDG-03: Good health and well-being
Sustainable Development Goals
SDG-03:Good heatlh and well-being
Citation
Gascón, P., Harbeck, N., Rapoport, B.L. et al. 2024, 'Filgrastim biosimilar (EP2006): a review of 15 years’ post-approval evidence', Critical Reviews in Oncology/Hematology, vol. 196, art. 104306, pp. 1-11, doi : 10.1016/j.critrevonc.2024.104306.