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BIO Submits Comments on FDA Draft Guidances on Biosimilars

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The Biotechnology Industry Organization (BIO) submitted comments yesterday to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on biosimilar products.</p>

Washington, D.C. (April 17, 2012) – The Biotechnology Industry Organization (BIO) submitted comments yesterday to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on biosimilar products.

“BIO supports the FDA’s ongoing implementation of a science-based pathway for the review and approval of biosimilars that protects patient safety and promotes continued innovation,” stated Sara Radcliffe, Executive Vice President, Health.  “We appreciate the opportunity to request clarity on scientific and policy issues within the three draft guidance documents.”

BIO intends to provide testimony at the FDA public hearing on the draft guidances scheduled for May 11, 2012.

Read BIO’s comments on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: www.bio.org/biosimilars/scientific-considerations  

Read BIO’s comments on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product: www.bio.org/biosimilars/quality-considerations

Read BIO’s comments on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: www.bio.org/biosimilars/questions-answers

 

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BIO IP Counsels Committee Conference
April 16 – 18, 2012
Austin, TX

World Congress on Industrial Biotechnology & Bioprocessing
April 29-May 2, 2012
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2012 BIO International Convention
June 18-21, 2012
Boston, MA

BIO Business Forum
June 18 – 21, 2012
Boston, MA