FDA has published 48 finalized product-specific guidances describing its current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.
The Agency said that, to successfully develop and manufacture a generic drug product, an applicant should consider that their product is expected to be pharmaceutically equivalent to its reference listed drug (RLD), bioequivalent to the RLD, and therapeutically equivalent, which means it needs to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug.
According to 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product. Under this regulation, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24. As the initial step for selecting methodology for generic drug product development, applicants are referred to this draft guidance.
To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.