FDA and EMA Biosimilar Approvals

  • Emily H. Jung
  • Ameet SarpatwariEmail author
  • Aaron S. Kesselheim
  • Michael S. Sinha
Concise Research Report


In 2010, Congress streamlined Food and Drug Administration (FDA) approval of versions of biologic drugs made by other manufacturers (“biosimilars”) after market exclusivity expiration. This pathway, codified in section 351(k) of the Public Health Service Act, was intended to leverage existing knowledge about originator biologics to require fewer trials. By reducing cost of entry, policymakers incentivized competition and lower drug prices.

Biosimilar market growth, however, has been slow.1 The FDA approved its first biosimilar in 2015.2 As of February 2019, 17 biosimilars of 9 originator biologics had received regulatory approval, but only 7 had been marketed with limited price reductions.3 Concern has arisen whether biosimilar testing requirements have hindered market entrants, leading some to doubt that the US biosimilar marketplace will eventually flourish.4

Europe has had more experience with biosimilars than the USA. The European Medicines Agency (EMA) approved its...


Funding Information

This study was funded by Arnold Ventures. Dr. Sarpatwari and Dr. Kesselheim’s work is additionally supported by the Harvard-MIT Center for Regulatory Science and the Engelberg Foundation.


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    Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS. The US biosimilar market: stunted growth and possible reforms. Clin Pharmacol Ther. 2019;105(1):92–100.CrossRefGoogle Scholar
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    Sarpatwari A, Avorn J, Kesselheim AS. Progress and hurdles for follow-on biologics. N Engl J Med. 2015;372(25):2380–2.CrossRefGoogle Scholar
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    Zhai MZ, Sarpatwari A, Kesselheim AS. Should biosimilars continue to be adopted in the US? AMA J Ethics. 2019;21(8):E668‐678.Google Scholar
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    Atteberry P, Bach PB, Ohn JA, Trusheim M. Biologics Are Natural Monopolies (Part 1): Why Biosimilars Do Not Create Effective Competition. Health Affairs Blog. 15 April 2019.
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    Medicines. European Medicines Agency. Accessed 25 June 2019.

Copyright information

© Society of General Internal Medicine 2019

Authors and Affiliations

  1. 1.Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of MedicineBrigham and Women’s Hospital and Harvard Medical SchoolBostonUSA
  2. 2.Harvard-MIT Center for Regulatory ScienceHarvard Medical SchoolBostonUSA

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