Perspectives on the Current State of the Biosimilar Regulatory Pathway in the United States

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 ref...

Full description

Saved in:
Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2018-01, Vol.103 (1), p.36-38
Main Authors: Dougherty, Michele K., Zineh, Issam, Christl, Leah
Format: Article
Language:English
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.909