Imperative To Recognize Differences Between Biologics and Other Drugs
WASHINGTON, Sept. 29 /PRNewswire/ -- Biotechnology Industry
Organization (BIO) President and CEO Jim Greenwood issued the following
statement today regarding legislation introduced by Senator Charles
Schumer, Senator Hillary Rodham Clinton and U.S. Representative Henry
Waxman regarding follow-on biologics:
"Biological products are fundamentally different from traditional drugs
in their complexity, development and production processes. As a result of
these differences, significant scientific and safety issues must be
addressed before moving to establish any legislative or regulatory pathway
for the approval of follow-on biological products.
"BIO believes that any evaluation of whether or how to authorize such a
pathway must fully address both how to ensure patient safety and how to
maintain incentives that spur continued innovation, including strong
protections for intellectual property rights and access to capital.
"It is critical in the first instance to recognize the substantive and
important differences between biologics and traditional drugs. Unlike most
traditional drugs, biologics are complex substances produced using living
organisms. It is imperative that the U.S. Food and Drug Administration
(FDA) continue to require a full complement of data, including clinical
evidence, to demonstrate safety and effectiveness for all biotechnology
products. Patients should not have to accept greater risks or uncertainties
in using a follow-on product than when they use an innovator's product.
"A number of complex issues regarding intellectual property (IP) and
trade secrets also must be considered. Any pathway to the development of a
follow- on product must not reduce or infringe the IP rights of innovator
companies. A legal framework for such a pathway must recognize the
importance of intellectual property rights as a catalyst for innovation and
provide adequate protections to help ensure companies are able to compete
for and secure the capital necessary for innovation.
"For more than 20 years, the exceptional creativity of the
biotechnology industry has been directed toward discovering, developing,
and delivering innovative treatments for patients worldwide, in many cases
providing the first approved treatment for a condition. BIO members invest
heavily in research and development, and are committed to creating new
therapies that will help patients live longer and better lives. We want to
ensure our continued ability to do so. We hope to work with the full
Congress, the FDA and all other key stakeholders should this debate move
forward."
About BIO
BIO represents more than 1,100 biotechnology companies, academic
institutions, state biotechnology centers and related organizations across
the United States and 31 other nations. BIO members are involved in the
research and development of healthcare, agricultural, industrial and
environmental biotechnology products. http://www.bio.org
SOURCE Biotechnology Industry Organization
 back to top
Related links:
http://www.bio.org/
CONTACT:
Jeff Joseph of Biotechnology Industry
Organization, +1-202-962-9230
|
