Bioequivalence assessment of generic drugs: an American point of view.

Abstract

Consistent quality and performance characteristics for the innovator (brand name) drug products and their generic (multisource) equivalents are explicit objectives of the drug approval process in the US. Statutory and regulatory requirements supporting these objectives are based on the bioavailability and bioequivalence Regulations (1), the amendments to the Food, Drug and Cosmetic Act (2), and the implementing regulations to the amendments. These objectives are based on the concept that an innovator drug exists with reproducible quality and performance characteristics that are maintained throughout the marketing life. Following termination of the patent or the exclusivity period for an innovator drug product, its generic pharmaceutical equivalents may be marketed. These generic drug products are expected to demonstrate comparable quality and performance characteristics to those of the innovator product throughout the marketing period. In addition, both innovator and generic drug products may undergo several post-approval changes in formulation and manufacturing processes, change of manufacturing site, and increase in batch size, etc., that may warrant demonstration of sustained quality and performance characteristics. Several drug application and compendial tests and specifications exist to assure the overall objective of stability in the quality and the performance characteristics of the innovator and