Analysis of the Regulatory Policies Progress of Biosimilars in Foreign Countries and Its Enlightenment to China / 中国药房

ABSTRACT

OBJECTIVE:To explore the development status of regulatory policies of biosimilars in foreign countries,and to provide reference for perfecting biosimilars regulatory policies in China. METHODS:Comparative analysis was conducted,con-cerning biosimilar regulations and directories which had been issued by WHO,EMA and FDA,in aspects of biosimilars definition, the choice of reference drug,quality studies,non-clinical studies,clinical studies. RESULTS & CONCLUSIONS:Three common points found in foreign regulatory policies were thatfirstly,discrepancies were allowed between biosimilars and reference drugs;secondly,the comparison was itemized between biosimilars and reference drugs on safety and effectiveness,in order to guarantee the reliability of quality research;thirdly,clinical and non-clinical studies were reduced with a premise that similarity is confirmed. Given China's current situation,several parts of policies should be improved,including stressing pertinence of reference drug selec-tion,refining preclinical and clinical study directories and establishing supporting system after listing.