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Pharmacokinetics and Generic Drug Switching: A Regulator's View
Pieter J Glerum1,2, Cees Neef2, David M Burger3
1Medicines Evaluation Board, CBG-MEB, P.O. Box 8275, 3503 GB, Utrecht, The Netherlands.
Clinical Pharmacokinetics
|June 20, 2020
Summary
Clinical discomfort after switching generic drugs is due to natural pharmacokinetic variability, not drug quality. Current bioequivalence testing adequately ensures therapeutic equivalence for generic medications.
Area of Science:
- Pharmacokinetics and Drug Regulation
- Clinical Pharmacology
Background:
- Reported clinical discomfort and adverse drug reactions following generic drug use and switches suggest a potential mismatch with assumed therapeutic equivalence.
- The interchangeability of generic drugs is often questioned despite regulatory approval based on bioequivalence.
Purpose of the Study:
- To evaluate the sufficiency of the current regulatory approach for generic drug evaluation based on average bioequivalence.
- To address the debate surrounding therapeutic equivalence and clinical outcomes after switching generic medications.
Main Methods:
- Analysis of the relationship between pharmacokinetic within-subject variability and reported clinical discomfort.
- Review of the regulatory framework for assessing bioequivalence of generic drugs.
Main Results:
- Clinical discomfort during bioequivalent drug switches is attributed to inherent pharmacokinetic within-subject variability, not drug quality.
- This variability in bioavailability, not drug characteristics, explains differences in active substance exposure.
Conclusions:
- The current regulatory approach using average bioequivalence is sufficient for ensuring therapeutic equivalence in clinical practice.
- Reported clinical discomfort does not necessitate a change in the regulatory evaluation of generic drug bioequivalence.
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