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The US Biosimilar Market: Stunted Growth and Possible Reforms
Author(s) -
Sarpatwari Ameet,
Barenie Rachel,
Curfman Gregory,
Darrow Jonathan J.,
Kesselheim Aaron S.
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1285
Subject(s) - biosimilar , food and drug administration , drug approval , pharmacology , business , medicine , marketing , drug
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.