Eshoo-Barton Biologics Bill Marks Important Step Forward Toward Follow-On Biologics,...

Fri Mar 14, 2008 1:28pm EDT

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

  New Legislation Recognizes Importance of Patient Safety, Promoting
                              Innovation
WASHINGTON--(Business Wire)--
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."

   About BIO

   BIO represents more than 1,150 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
technologies. BIO also produces the annual BIO International
Convention, the world's largest gathering of the biotechnology
industry, along with industry-leading investor and partnering meetings
held around the world. www.bio.org

   Upcoming BIO Events

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--  BIO-Europe Spring
    April 7-9, 2008
    Madrid, Spain

--  BIO National Venture Conference
    April 22-23, 2008
    Boston, Mass

--  World Congress on Industrial Biotechnology & Bioprocessing
    April 27-30, 2008
    Chicago, Ill.

--  2008 BIO International Convention
    June 17-20, 2008
    San Diego, Ca.
*T

Biotechnology Industry Organization (BIO)
Jeff Joseph, 202-962-9230
www.bio.org

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