New Senate Biosimilars Proposal Would Jeopardize New Medical Advancements and Cures
WASHINGTON, July 08, 2009 - The following statement was
issued today by the Biotechnology Industry Organization (BIO)
regarding a proposal to establish a pathway for regulatory approval
of biosimilars reportedly under consideration in the Senate
Committee on Health, Education, Labor and Pensions (HELP):
“The Committee mark reportedly under consideration in the
Senate HELP Committee would undermine hope for potential cures and
new advanced medicines. The proposal would provide a
limited and highly uncertain period of data exclusivity that would
chill the investment required to improve existing drugs and develop
the next generation of medicines and potential cures for
patients.
“This proposal would represent a stark break from
the agreement struck in the Biologics Price Competition and
Innovation Act of 2007, S. 1695, introduced By Senator Kennedy
and Senator Mike Enzi (R-WY) in the 110th
Congress. The Senate should return to the original
agreement.
“The new proposal purports to establish up to 13 years of
data exclusivity but, in actuality, many biologics would receive
zero years of exclusivity. The language as proposed provides
9 years of base data exclusivity only to a new ‘major’
substance. Any product that is even similar to a
previously approved product, in some undefined way, could get zero
years of exclusivity.
“In addition, the proposal provides 9 years of data
exclusivity only to those new biologics approved after the
bill’s passage. A product approved even one day before
the bill becomes law would get zero years of exclusivity, providing
no protection.
“Such an abbreviated and uncertain period of exclusivity
could lead to a dead end for many new biomedical advancements and
potential cures for devastating diseases such as cancer,
Parkinson’s, Alzheimer’s, Multiple Sclerosis and a host
of rare diseases. It also would jeopardize more than
7.5 million U.S. jobs driven by biotechnology and our
nation’s leadership in biomedical
innovation.
“In the end, this new proposal would provide fewer incentives
for the uniquely American biotech industry than the European Union
provides and it would create an incredibly complicated structure
filled with uncertainty that would scare off investors and, in
turn, potentially stifle efforts to pursue medical advancements and
breakthroughs for patients.
“We urge the HELP Committee to reject this proposal, if
offered. We look forward to working with the Senate as it
considers this vital issue.”
Upcoming BIO
Events
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Biotechnology & Bioprocessing
July 19-22, 2009
Montreal, Quebec, Canada
BIO
Investor Forum
October 28-29, 2009
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October 30, 2009
Vienna, Austria
BIO
Europe International Partnering Conference
November 2-4, 2009
Vienna, Austria
Pacific Rim Summit on Industrial
Biotechnology and Bioenergy
November 8-11, 2009
Honolulu, HI
About BIO
BIO represents more than 1,200 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.
Contact Jeff Joseph
202-962-9230
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