Interchangeability: Generic Drugs

Authored by: Jiayin Zheng , Shein-Chung Chow , Mengdie Yuan

Encyclopedia of Biopharmaceutical Statistics

Print publication date:  August  2018
Online publication date:  August  2018

Print ISBN: 9781498733953
eBook ISBN: 9781351110273
Adobe ISBN:


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With more and more generics becoming available in the marketplace, the safety/efficacy concerns may arise as the result of interchangeably use of approved generics. However, bioequivalence assessment for regulatory approval among generics of the innovative drug product is not required. In practice, approved generics are often used interchangeably without any mechanism of safety monitoring. In this article, based on indirect comparisons, we introduce several methods to assessing bioequivalence and interchangeability between generics. The applicability of the methods and the similarity assumptions were discussed, as well as the inappropriateness of directly adopting adjusted indirect comparison to the field of generics’ comparison. Besides, some extensions were given to take into consideration the important topics in clinical trials for bioequivalence assessments, e.g., multiple comparisons and simultaneously testing bioequivalence among three generics. Two real examples, the studies of malaria generics and HIV/AIDS generics prequalified by the WHO, were used to demonstrate the use of the method.

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