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Amgen To Provide Testimony At FDA Stakeholder Hearing On Biosimilars
Date:5/11/2012

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On March 23, 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act which contained a provision authorizing the FDA to create an abbreviated approval pathway for biological products shown to be biosimilar to an already FDA-approved biological medicine.  Several countries around the globe have already implemented approval pathways for biosimilars.  The European Union and Japan are among those that have successfully devised a set of science-based criteria to permit biosimilars in their jurisdictions.  As a result of the FDA public hearing in November 2010 and the FDA's draft guidances on biosimilars issued on Feb. 9, 2012, the U.S. is beginning the implementation process.

In response to the FDA draft guidances on biosimilars issued on Feb. 9, 2012, Amgen submitted comments by the FDA's April 16, 2012 deadline. A complete listing of Amgen's comments can be accessed on the regulations.gov website and are  posted by docket number:

Scientific Considerations Draft Guidance:
http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0605-0034

Quality Considerations Draft Guidance:
http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0602-0030

Q&A Draft Guidance:
http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0611-0033

Miletich's written testimony was submitted in response to FDA's notice announcing a public hearing and requesting public comments on "Draft Guidances Relating to the Development of Biosimilar Products." His testimony is available at 

SOURCE Amgen
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