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Comment & Response
September 26, 2017

Challenges to Biosimilar Substitution

Author Affiliations
  • 1Arnold School of Public Health, University of South Carolina, Columbia
  • 2College of Health and Human Services, George Mason University, Fairfax, Virginia
  • 3South Carolina College of Pharmacy, University of South Carolina, Columbia
JAMA. 2017;318(12):1186. doi:10.1001/jama.2017.11930

To the Editor We agree with Mr Hakim and Dr Ross1 that biosimilars in the United States are unlikely to yield widely expected cost savings and proffer an additional explanation: the frequency and complexity of biosimilar-related patent litigation have thus far resulted in too few marketed biosimilars.2 Only 2 of the 5 biosimilars approved by the US Food and Drug Administration (FDA) are now commercially available. As noted in the Viewpoint, prices for small molecule drugs drop 70% to 90% following generic approval, but these savings reflect competition after the entry of multiple generics, which is unlikely to occur anytime soon with biosimilars.3