Requirements of FDA for biosimilarity studies of clinical pharmacology of biosimilars / 药物评价研究

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.