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FDA Releases New Guidance for Biosimilar Applications

  • 05.14.14
  • Timothy J. Shea, Jr. and Paul A. Calvo, Ph.D.
Yesterday, the U.S. Food and Drug Administration provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical pharmacology data it wants to see to support a finding that a therapeutic biological product is biosimilar to a reference product.
 
This most recent guidance document comes more than one year after the last guidance document from the FDA specifically addressing biosimilars, and continues the agency’s slow and cautious implementation of the Biologics Price Competition and Innovation Act that was enacted in March of 2010.
 
To read our full client alert, download the attached PDF.

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