Hot Topics in Primary Care: Demystifying the Differences: Follow-on Biologics, Biosimilars, and Generics

J Fam Pract. 2017 Apr;66(4 Suppl):S22-S27.

Abstract

Sponsors of follow-on biologics can submit their applications for approval by the US Food and Drug Administration (FDA) under 2 distinct pathways. The submission pathway is determined by the pathway previously used by the reference biologic product, which is the biologic product upon which the follow-on product relies for evidence of safety and efficacy.

Publication types

  • Review

MeSH terms

  • Biosimilar Pharmaceuticals / classification*
  • Biosimilar Pharmaceuticals / standards*
  • Drug Approval / methods*
  • Drugs, Generic / classification*
  • Drugs, Generic / standards*
  • Guidelines as Topic*
  • Humans
  • Primary Health Care
  • United States
  • United States Food and Drug Administration

Substances

  • Biosimilar Pharmaceuticals
  • Drugs, Generic