Current regulatory approaches of bioequivalence testing

Area of Science:

• Pharmacokinetics and Drug Regulation
• Pharmaceutical Sciences

Background:

• Reducing healthcare costs is a priority for health agencies.
• Generic drug prescriptions are a key strategy for lowering medication expenses.
• Therapeutic equivalence between generic and brand-name drugs is typically established through bioequivalence testing.

Purpose of the Study:

• To review current regulatory procedures for bioequivalence testing.
• To focus on guidelines from the European Medicines Agency and US Food and Drug Administration.
• To explore the evolution of bioequivalence assessment and proposed alternatives.

Main Methods:

• Review of current regulatory guidelines on bioequivalence.
• Analysis of European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recommendations.
• Literature review of proposed alternatives and historical evolution of bioequivalence assessment.

Main Results:

• Bioequivalence, defined as no significant absorption differences, is complex in practice.
• Regulatory authorities have clarified many aspects of bioequivalence.
• Several challenges remain in bioequivalence assessment, particularly for complex drugs.

Conclusions:

• The scientific and regulatory basis of bioequivalence is intricate.
• Unresolved issues include assessing complex drugs (biologics, iron-carbohydrates), immunosuppressants, and the role of pharmacogenomics.
• Continued research and regulatory refinement are needed for comprehensive bioequivalence evaluation.