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Filgrastim biosimilar (EP2006): A review of 15 years' post-approval evidence.
Gascón, Pere; Harbeck, Nadia; Rapoport, Bernardo L; Anderson, Ronald; Brueckmann, Ines; Howe, Sebastian; Aapro, Matti.
Afiliación
  • Gascón P; Division of Medical Oncology, IDIBAPS, Hospital Clinic, Casanova 143, Barcelona 08036, Spain.
  • Harbeck N; Breast Center, Department OB&GYN and Center for hereditary Breast and Ovarian Cancer, LMU University Hospital, Marchioninistraße 15, Munich 81377, Germany.
  • Rapoport BL; The Medical Oncology Centre of Rosebank, 129 Oxford Road, Johannesburg 2196, South Africa; Department of Immunology, Pathology Building, Faculty of Health Sciences, University of Pretoria, Pretoria 0001, South Africa.
  • Anderson R; Department of Immunology, Pathology Building, Faculty of Health Sciences, University of Pretoria, Pretoria 0001, South Africa.
  • Brueckmann I; Sandoz Group AG, Global Medical Affairs, Industriestr. 25, Holzkirchen D-83607, Germany.
  • Howe S; Sandoz Group AG, Global Medical Affairs, Industriestr. 25, Holzkirchen D-83607, Germany. Electronic address: sebastian.howe@sandoz.com.
  • Aapro M; Cancer Center, Clinique de Genolier, Route du Muids 3, Genolier 1272, Switzerland.
Crit Rev Oncol Hematol ; 196: 104306, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38401695
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biosimilares Farmacéuticos / Neutropenia Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Crit Rev Oncol Hematol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Biosimilares Farmacéuticos / Neutropenia Límite: Humans País/Región como asunto: America do norte Idioma: En Revista: Crit Rev Oncol Hematol Asunto de la revista: HEMATOLOGIA / NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos