PP10-78: Risk-based Assessment of Generic Drug Storage Conditions That Differ from Reference Listed Drugs (RLD)

Poster Presenter

Jin Xu

Chemical Engineer, OLDP, OPQ, CDER
FDA
United States

Objectives

The objective of this presentation is to describe the underlining principles for quality assessment of proposed generic drug storage conditions that differ from RLD. Case studies will be presented to illustrate how FDA reviewers assess proposed generic drug storage conditions that differ from RLD.

Method

In this presentation, we use a few abbreviated generic drug applications as examples to illustrate the underlining principles for quality assessment of proposed generic drug storage conditions that differ from RLD.

Results

Generic drugs must be therapeutically equivalent to their RLD. A generic drug is deemed therapeutically equivalent to its RLD when it has been demonstrated bioequivalent and pharmaceutically equivalent to its RLD. Because generic drugs are pharmaceutically equivalent to their RLD, the proposed storage conditions of generic drugs are typically the same as their respective RLD. Under certain conditions, however, the proposed generic drug storage conditions may be allowed to differ from RLD. FDA reviewers assess the proposed generic drug storage conditions using a risk-based approach with the following guiding principles- • The proposed generic drug storage conditions should not be more stringent than the RLD because more stringent storage conditions of generic drugs than the RLD could indicate inferior generic drug stability compared to the RLD. • The proposed generic drug storage conditions that differ from RLD must be fully supported by stability data, including necessary in-use stability data. • Generic drugs with proposed storage conditions different from the RLD must be stable if stored under the storage conditions of the RLD to support the interchangeability of generic drugs with their RLD. • The proposed generic drug storage conditions different from RLD should be supported by adequate scientific rationales (i.e., why the generic is more stable than the RLD). Case studies will be offered to elaborate the above principles.

Conclusion

In conclusion, the risk-based approach to quality assessment of proposed generic drug storage conditions that differ from RLD emphasizes on the underlining scientific principles – while the proposed generic drug storage conditions may be allowed to differ from their RLD, the proposed generic drug storage conditions should not compromise generic drug product quality and the generic drugs’ interchangeability with their RLD. Additional authors of the poster abstract are: Sherry Bai, Ashay Mehta, and Geoffrey Wu Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, CDER/FDA