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Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States
Author(s) -
Dougherty Michele K.,
Zineh Issam,
Christl Leah
Publication year - 2018
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.909
Subject(s) - biosimilar , licensure , food and drug administration , pharmacology , medicine , drug approval , drug development , business , drug , medical education
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure pathway in the United States that allows for the development and approval of biologic products shown to be biosimilar to or interchangeable with a US Food and Drug Administration (FDA)‐licensed reference product (Table 1). Here we discuss implementation of the US biosimilar approval pathway and the role of various types of data, including clinical pharmacology data, in biosimilar development.