摘要
由于生物制品的复杂性,化学仿制药物的研究方法并不完全适用于生物仿制药物。本文将就国内外对于生物仿制药注册申请的相关技术要求进行简要回顾,并从药品评价角度提出一些对于生物仿制药药学研究问题的个人观点和看法。
Due to the complexity of biological products the generic approach which is normally applied to chemically derived medicinal products is not appropriate for similar biological medicinal products.This article briefly reviews the technical requirements for registration of these biosimilar products,and discusses some issues about CMC requirements of these products.
出处
《中国药事》
CAS
2008年第1期23-25,58,共4页
Chinese Pharmaceutical Affairs
关键词
生物仿制药物
研究方法
药品评价
biological generic drug
research direction
drug evaluation
