Similar concerns

Daly, Rich
July 2011
Modern Healthcare;7/11/2011, Vol. 41 Issue 28, p38
Trade Publication
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.


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