Why Are Biosimilars Not Living up to Their Promise in the US?

AMA J Ethics. 2019 Aug 1;21(8):E668-678. doi: 10.1001/amajethics.2019.668.


Biologics are among the most expensive prescription drugs in the United States, posing significant barriers to patient access to necessary treatments. An abbreviated approval pathway for biosimilars, near-identical versions of biologics made by different manufacturers, was created by Congress in 2010 to stimulate competition in hopes of driving down costs and expanding access. However, as of February 2019, only 17 biosimilars have been approved, with only 7 currently on the market. Of the few biosimilars currently available to patients, overall utilization has been limited. This article examines the current landscape of the biosimilar market, characterizes tactics employed by biologics manufacturers to delay market entry and deter prescribing of biosimilars, and assesses ethical issues related to increasing the adoption of biosimilars.

MeSH terms

  • Biosimilar Pharmaceuticals / economics*
  • Biosimilar Pharmaceuticals / supply & distribution*
  • Drug Industry / legislation & jurisprudence*
  • Jurisprudence*
  • Patents as Topic / legislation & jurisprudence*
  • Prescription Drugs / economics*
  • United States
  • United States Food and Drug Administration


  • Biosimilar Pharmaceuticals
  • Prescription Drugs