Analysis of the Regulatory Policies Progress of Biosimilars in Foreign Countries and Its Enlightenment to China
10.6039/j.issn.1001-0408.2016.01.03
- VernacularTitle:国外生物类似药监管政策发展分析及对我国的启示
- Author:
Li JIU
;
Xia HE
;
Wei LI
- Publication Type:Journal Article
- Keywords:
Biosimilars;
Regulatory policies;
Comparative studies;
Improvement
- From:
China Pharmacy
2016;27(1):8-11
- CountryChina
- Language:Chinese
-
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 that:firstly,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.
