BIO Submits Comments on FDA Draft Guidances on Biosimilars

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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Industry Organization (BIO) submitted comments yesterday to the U.S. Food and Drug Administration (FDA) on three draft guidance documents on biosimilar products.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  “We appreciate the opportunity to request clarity on scientific and policy issues within the three draft guidance documents.”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:  

Read BIO’s comments on Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product:

Read BIO’s comments on Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009:


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About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.