FDA's three draft guidances on biosimilars - BIO submits comments

Apr 18 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Industry Organization (BIO) submitted comments yesterday to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on biosimilar products.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”

"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 "We appreciate the opportunity to request clarity on scientific and policy issues within the three draft guidance documents."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