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Comment & Response
December 22/29, 2015

Competition and Biosimilar Products

Author Affiliations
  • 1Sandoz Inc, Princeton, New Jersey
JAMA. 2015;314(24):2691-2692. doi:10.1001/jama.2015.15052

To the Editor Drs Chandra and Vanderpuye-Orgle1 discussed ways that public policy might increase the competitive benefits of biosimilars. However, there are several misconceptions in their article that we think may have the opposite effect—hindering adoption and limiting competitive benefits.

The introduction of biosimilars in the United States represents an opportunity to bring competition to the marketplace and improve access to expensive biologics. Biosimilar development focuses on producing “essentially the same biological substance” as the reference product and demonstrates “sameness” through physicochemical and biological comparative analyses.2 Biosimilars are required to have the same amino acid sequence as the reference.