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

The US Biosimilar Market: Stunted Growth and Possible Reforms.

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1
Program On Regulation, Therapeutics, And Law (PORTAL), Department of Medicine, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.

Abstract

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.

PMID:
30415479
DOI:
10.1002/cpt.1285

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