Eshoo-Barton Biologics Bill Marks Important Step ForwardToward Follow-On Biologics, Says BIO

New Legislation Recognizes Importance of Patient Safety, Promoting Innovation                 WASHINGTON, D.C. (Friday, March 14, 2008) - Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding legislation introduced yesterday by Rep. Anna Eshoo (D-CA) and Rep. Joe Barton (R-TX) that would develop a regulatory pathway for approving follow-on biologics:

                "BIO commends U.S. Representatives Anna Eshoo and Joe Barton for taking a strong, bipartisan step forward toward developing a pathway for the approval of follow-on biologics – products that seek to imitate pioneering biotechnology medicines.  The bill introduced yesterday includes essential elements to ensure that any such pathway follows two critical principles: namely, protecting patient safety and ensuring continued innovation.

                "Importantly, the bill recognizes the need to protect patient safety by calling for a set of studies demonstrating the safety and efficacy of the follow-on product, including clinical and immunogenicity studies.

                “The proposal also establishes a mechanism for the U.S. Food and Drug Administration (FDA) to advise whether it is feasible, based on current science, to make a determination that a follow-on product is interchangeable with the pioneering biotech therapy.  While this provision improves upon previous legislative proposals, we continue to believe that patients should not be given follow-on biologics unless expressly prescribed by a physician.

                "The legislation further seeks to provide pioneering biotechnology companies with a level of non-patent data exclusivity to promote continued innovation, although it falls short of the base 14 years that has been demonstrated to be the needed period required to strike the right balance between providing incentives for innovation and follow-on product entry.  Non-patent exclusivity is necessary to maintain effective market protection to attract the hundreds of millions of dollars necessary to research and develop an innovative new biotech therapy or technology.

                 "Some special interests publicly say they want to delay follow-ons legislation until next year or beyond.  We urge Congress to pass the right bill as soon as possible.  It is time all parties work together to place patient needs before political gamesmanship.  The time is now to pass a pro-patient, pro-innovation, pro-science follow-on biologics bill."

                 "We thank Representatives Eshoo and Barton for their leadership and for underscoring the importance of a bipartisan approach toward developing a follow-ons pathway.  We pledge to continue to work with the House Committee on Energy and Commerce, under the leadership of Chairman Dingell, and all members of Congress to finalize and pass a balanced, bipartisan follow-on biologics bill as soon as possible."