Requirements of FDA for biosimilarity studies of clinical pharmacology of biosimilars
10.7501/j.issn.1674-6376.2017.05.002
- VernacularTitle:FDA对生物类似药临床药理学生物相似性研究的要求
- Author:
Huilai XIAO
- Keywords:
FDA;
biosimilar;
clinical pharmacology;
biosimilarity;
guidance
- From:
Drug Evaluation Research
2017;40(5):586-592
- CountryChina
- Language:Chinese
-
Abstract:
FDA released Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product Guidance for Industry in December,2016.The guidance describes the requirements of the trial designs and trial methods for the biosimilar clinical pharmacological studies,and especially points out the problems that should be paid special attention to in the studies.However there is no similar guidance in China.This paper introduces the guidance of FDA,which is beneficial to the research and regulation in China.
