Clinical comparability and European biosimilar regulations

被引：73
作者：
Schellekens, Huub [1 ,2 ]
Moors, Ellen [2 ]
机构：
[1] Univ Utrecht, Dept Pharmaceut Sci, Utrecht, Netherlands
[2] Univ Utrecht, Dept Innovat Studies, Utrecht, Netherlands
来源：
NATURE BIOTECHNOLOGY | 2010年 / 28卷 / 01期
关键词：
D O I：
10.1038/nbt0110-28
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of biosimilars of more complicated biologics.
引用
收藏
页码：28 / 31
页数：4
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