TITLE

Similar concerns

AUTHOR(S)
Daly, Rich
PUB. DATE
July 2011
SOURCE
Modern Healthcare;7/11/2011, Vol. 41 Issue 28, p38
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
The article discusses the U.S. Food and Drug Administration's (FDA) regulatory approval process for biological medicines and their generic versions. The FDA started creating guidelines to determine the effectiveness and safety of the generic versions of biosimilars or protein-based drugs. An overview of the Biologics Price Competition and Innovation Act is provided. Patient advocates and members of the U.S. Congress also expressed concerns on the approval process.
ACCESSION #
62951366

 

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