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Related Experiment Videos

Therapeutic inequivalence.

P H Rheinstein1

  • 1Center for Drug Evaluation and Research, Food and Drug, Administration, Rockville, Maryland.

Drug Safety
|January 1, 1990
PubMed
Summary
This summary is machine-generated.

Generic drugs aim for therapeutic equivalence to innovator drugs, with regulatory approval based on bioequivalence. While a small risk of inequivalence exists, properly manufactured generics approved by the FDA show no evidence of this.

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Area of Science:

  • Pharmacology
  • Regulatory Science
  • Drug Development

Background:

  • Therapeutic inequivalence occurs when expected therapeutic equivalence is absent.
  • Generic drug regulation in the USA differs for pre- and post-1938 drugs.
  • Bioequivalence demonstration is crucial for generic drug approval.

Purpose of the Study:

  • To define therapeutic inequivalence in the context of generic drugs.
  • To outline the regulatory requirements for generic drug approval in the USA.
  • To assess the risk-benefit profile and regulatory aims for generic medications.

Main Methods:

  • Review of US regulatory requirements for generic drugs.
  • Definition of bioequivalence criteria (+/- 20% difference in rate and extent of absorption).

Related Experiment Videos

  • Analysis of the risk of therapeutic inequivalence during drug switching.

    • Main Results:

    • Generic drugs of post-1938 innovators require bioequivalence demonstration.
    • Bioequivalent generics are expected to be therapeutically equivalent and less expensive.
    • No evidence of therapeutic inequivalence in FDA-approved, bioequivalent generic drugs exists.

    Conclusions:

    • Generic drug regulation aims to minimize therapeutic inequivalence while preserving economic benefits.
    • A small risk of therapeutic inequivalence exists when switching between innovator and generic drugs.
    • Therapeutic inequivalence is more readily detected in institutional settings than in individual patient care.