The Backlash Against Bioequivalence and the Interchangeability of Brand-Name and Generic Drugs

Kesselheim AS - Canadian Medical Association Journal

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence

Summary:

The author addresses skepticism about generic drug interchangeability, arguing that while case reports of adverse outcomes from generic substitution have fueled concerns, particularly for narrow therapeutic index drugs, the overall evidence strongly supports the bioequivalence framework, and that opposition is often driven by anecdote rather than systematic data.

VIEW SOURCE

Recent Work from PORTAL

Talk bubble graphics representing commentary and opinion.

How Congress Can Fix Expert Advisory Committees

Daval CJR, Kesselheim AS - STAT

  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

International Regulatory Status and Reimbursement Recommendations of Haematological Malignancy Drugs Withdrawn from the FDA Accelerated Approval Pathway

Mulsant SS, Kesselheim AS, Naci H - Journal of Cancer Policy

  • Price, Value, and Access
  • Regulation and Clinical Evidence
An icon of a bill representing government policy.

Comments on FDA Discussion Paper, “Considerations for the Regulation of Generative AI-Enabled Medical Devices”

Jaiswal N, Gorijavolu R, Thomas S, Hwang TJ, Celi LA, Kesselheim AS - Food and Drug Administration (FDA)

  • Regulation and Clinical Evidence