Mellstedt H, Niederwieser D, Ludwig H
Cancer Centre Karolinska, Department of Oncology, Karolinska University Hospital Solna, Stockholm, Sweden.
Ann Oncol. 2008 Mar;19(3):411-9. doi: 10.1093/annonc/mdm345. Epub 2007 Sep 14.
The purpose of this report was to review issues associated with the introduction of alternative versions of biosimilars used in the oncology setting.
Data were obtained by searches of MEDLINE, PubMed, references from relevant English-language articles, and guidelines from the European Medicines Agency.
When biosimilars are approved in EU, they will be considered 'comparable' to the reference product, but this does not ensure therapeutic equivalence. Inherent differences between biosimilars may produce dissimilarities in clinical efficacy, safety, and immunogenicity. Switching biosimilars should be considered a change in clinical management. Regulatory guidelines have been established for some biosimilar categories but, because of the limited clinical experience with biosimilars at approval, pharmacovigilance programs will be important to establish clinical databases. Guidelines also provide a mechanism for the extrapolation of clinical indications (approved indications for which the biosimilar has not been studied). This may be of concern where differences in biological activity can result in adverse outcomes or when safety is paramount (e.g. stem cell mobilization in healthy donors). These issues should be addressed in biosimilar labeling.
Biosimilars should provide cost savings and greater accessibility to biopharmaceuticals. A thorough knowledge surrounding biosimilars will ensure the appropriate use of biopharmaceuticals.
本报告旨在回顾与肿瘤学领域使用的生物类似药替代版本引入相关的问题。
通过检索MEDLINE、PubMed、相关英文文章的参考文献以及欧洲药品管理局的指南获取数据。
当生物类似药在欧盟获批时，它们将被视为与参照产品“可比”，但这并不确保治疗等效性。生物类似药之间的内在差异可能在临床疗效、安全性和免疫原性方面产生不同。更换生物类似药应被视为临床管理的改变。已针对某些生物类似药类别制定了监管指南，但由于获批时生物类似药的临床经验有限，药物警戒计划对于建立临床数据库很重要。指南还提供了一种临床适应症外推机制（生物类似药未针对其进行研究的获批适应症）。在生物活性差异可能导致不良后果或安全性至关重要的情况下（例如健康供体中的干细胞动员），这可能令人担忧。这些问题应在生物类似药标签中予以解决。
生物类似药应能节省成本并使生物制药更易获得。对生物类似药的全面了解将确保生物制药的合理使用。
