Assessing the safety and comparative effectiveness of follow-on biologics (biosimilars) in the United States

Clin Pharmacol Ther. 2010 Feb;87(2):157-9. doi: 10.1038/clpt.2009.249.

Abstract

As Congress begins drafting legislation concerning the US Food and Drug Administration (FDA) regulation of biosimilars, it is critical to keep in mind that these agents may differ from their innovator compounds. Therefore, it is of the utmost importance to be able to differentiate among innovators and biosimilars in administrative data in order to facilitate the conduct of population-based safety and comparative effectiveness studies. This Commentary proposes methods that would allow these agents to be distinguished in such data.

MeSH terms

  • Biological Products / adverse effects
  • Biological Products / pharmacology*
  • Comparative Effectiveness Research / methods*
  • Drug Approval
  • Drugs, Generic / adverse effects
  • Drugs, Generic / pharmacology*
  • Humans
  • Legislation, Drug*
  • Product Surveillance, Postmarketing / methods
  • Therapeutic Equivalency
  • Vereinigte Staaten
  • United States Food and Drug Administration

Substances

  • Biological Products
  • Drugs, Generic