Analysis of the Regulatory Policies Progress of Biosimilars in Foreign Countries and Its Enlightenment to China / 中国药房
China Pharmacy
;
(12): 8-11, 2016.
Article
in Chinese
| WPRIM
| ID: wpr-501393
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacy
Year:
2016
Type:
Article
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