The US Biosimilar Market: Stunted Growth and Possible Reforms

Clin Pharmacol Ther. 2019 Jan;105(1):92-100. doi: 10.1002/cpt.1285. Epub 2018 Dec 28.


In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the US Food and Drug Administration (FDA) had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulatory, and marketing issues that have limited biosimilar market entry and uptake, concluding with recommendations for reform.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Biosimilar Pharmaceuticals / chemistry
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Drug Approval / methods*
  • Drug Industry / methods*
  • Drug Industry / trends
  • Humans
  • Prescription Drugs / chemistry
  • Prescription Drugs / therapeutic use
  • United States
  • United States Food and Drug Administration* / trends


  • Biosimilar Pharmaceuticals
  • Prescription Drugs