Caselli Désirée, Cesaro Simone, Aricò Maurizio
Medical Department, Pediatric Unit, Azienda Sanitaria Provinciale Ragusa, Ragusa, Italy.
Department of Pediatrics, Pediatric Hematology Oncology, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
Biologics. 2016 Feb 18;10:17-22. doi: 10.2147/BTT.S73580. eCollection 2016.
Advances in chemotherapy and surgery allows the majority of patients to survive cancer diseases. Yet, the price may be a proportion of patients dying of complications due to treatment-induced infectious complications, such as neutropenia. With the aim of decreasing morbidity and mortality related to infectious complications, recombinant human granulocyte colony-stimulating factor (G-CSF), filgrastim, and pegylated filgrastim have been used to reduce time and degree of neutropenia. A biosimilar is a copy of an approved original biologic medicine whose data protection has expired. The patent for filgrastim expired in Europe in 2006 and in the US in 2013. This review analyses the available evidence to be considered in order to design a strategy of use of G-CSF and its biosimilars. The clinical and safety outcomes of biosimilars are well within the range of historically reported data for originator filgrastim. This underscores the clinical effectiveness and safety of biosimilar filgrastim in daily clinical practice. Biosimilars can play an important role by offering the opportunity to reduce costs, thus contributing to the financial sustainability of treatment programs.
化疗和手术的进展使大多数癌症患者得以存活。然而，代价可能是一部分患者死于治疗引起的感染性并发症，如中性粒细胞减少症。为了降低与感染性并发症相关的发病率和死亡率，重组人粒细胞集落刺激因子（G-CSF）、非格司亭和聚乙二醇化非格司亭已被用于缩短中性粒细胞减少的时间和减轻其程度。生物类似药是已获批准的原创生物药在数据保护期到期后的仿制品。非格司亭在欧洲的专利于2006年到期，在美国于2013年到期。本综述分析了为设计G-CSF及其生物类似药的使用策略而需考虑的现有证据。生物类似药的临床和安全性结果完全在原创非格司亭既往报告数据的范围内。这突出了生物类似药非格司亭在日常临床实践中的临床有效性和安全性。生物类似药通过提供降低成本的机会可发挥重要作用，从而有助于治疗方案的财务可持续性。
