In the United States, when an innovative (brand-name) drug product is going off patent, pharmaceutical and/or generic/biotech companies may file an abbreviated new drug application (ANDA) for approval of generic copies or a Biologic License Application (BLA) for approval of a biosimilar product of the innovative drug product. This article provides a comprehensive review of the criteria, design, and analysis for assessment of bioequivalence (generic drugs) and biosimilarity (biosimilar products). In addition, fundamental differences between the assessment of bioequivalence for generic drugs and biosimilarity for biosimilar products are compared. Some commonly encountered challenging issues and recent development in bioequivalence and biosimilarity assessment are also discussed.
Author(s): Shein-Chung Chow, Susan S. Chow, and Annpey Pong