Review of biosimilar regulatory guidelines and scientific principles:Experiences from Europe-an Medicines Agency (EMA) guidelines
10.3969/j.issn.1674-2982.2014.10.005
- VernacularTitle:生物类似物政策监管指南原则与要求研究综述--基于欧盟版生物类似物指南
- Author:
Ming CHEN
;
Rong SHAO
- Publication Type:Journal Article
- Keywords:
Biosimilars;
European Union;
European Medicines Agency;
Regulatory guidelines;
Scientific principles
- From:
Chinese Journal of Health Policy
2014;(10):21-26
- CountryChina
- Language:Chinese
-
Abstract:
In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.
