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What makes a generic medication generic?
1University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, PA 15213, USA. HowlandRH@upmc.edu
Journal of Psychosocial Nursing and Mental Health Services
|December 17, 2009
Summary
Generic drugs are approved by the U.S. Food and Drug Administration (FDA) without new safety research. They must prove bioequivalence to brand-name drugs, ensuring clinical equivalence and substitutability.
Area of Science:
- Pharmaceutical Sciences
- Drug Regulatory Affairs
Background:
- The U.S. Food and Drug Administration (FDA) can approve generic drugs without requiring new safety and efficacy research.
- Generic drug approval relies on demonstrating sameness to brand-name counterparts in key aspects.
Purpose of the Study:
- To explain the regulatory framework for generic drug approval by the FDA.
- To highlight the critical role of bioavailability and bioequivalence in generic drug evaluation.
Main Methods:
- Comparison of regulatory requirements for generic versus brand-name drugs.
- Explanation of the scientific principles of bioavailability and bioequivalence.
Main Results:
- Generic drugs must match brand-name drugs in active ingredients, strength, dosage form, and route of administration.
- Bioequivalence ensures that generic drugs deliver active ingredients at the same rate and extent, confirming clinical equivalence.
Conclusions:
- The FDA's approval process for generic drugs ensures they are safe and effective through bioequivalence studies.
- Bioequivalence is the cornerstone for establishing clinical equivalence, allowing for the substitution of generic drugs for brand-name drugs.
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