[Ip-health] BIO's press release on Eshoo/Barton biosimilar amendment

[James Love]

Almost immediately, BIO has a press release out.

http://bio.org/news/pressreleases/newsitem.asp?id=3D2009_0731_01

House Energy and Commerce Committee Vote Marks Another Step Forward on
Pathway to Biosimilars
=09Click here for a printer-friendly page Printer Friendly

Strong bipartisan support for inclusion of pathway in health care reform
legislation

For Immediate Release
7/31/2009


Contact:
Contact Stephanie Fischer
(202) 312-9263 or sfischer@bio.org

WASHINGTON, D.C. (July 31, 2009) - Biotechnology Industry Organization
(BIO) President and CEO Jim Greenwood released the following statement
on the approval of an amendment to create a regulatory pathway for
biosimilars by the House Energy and Commerce Committee in today=E2=80=99s
mark-up of the America=E2=80=99s Affordable Health Choices Act (H.R. 3200):

=E2=80=9CThe strong bipartisan support in the Energy and Commerce Committee=
 for
a fair and balanced pathway for the approval of biosimilars is a
decisive win for the patients of today and tomorrow.  The approved
amendment, introduced by Representatives Anna Eshoo (D, CA), Jay Inslee
(D, WA) and Joe Barton (R, TX), strikes the appropriate balance among
ensuring patient safety, expanding competition, reducing costs and
providing necessary and fair incentives that will provide for continued
biomedical innovation.  For these reasons, it has the support of a
variety of patient and academic organizations and other stakeholders
including the ALS Association, Alliance for Aging Research, Association
of American Universities and National Venture Capital Association.

=E2=80=9CThe amendment incorporates the principles of H.R. 1548, the Pathwa=
y for
Biosimilars Act, which has more than 140 cosponsors, and the amendment
offered by Senators Orrin Hatch (R, UT), Mike Enzi (R, WY) and Kay Hagan
(D, NC) in the recent mark-up of health care reform legislation in the
Health, Education, Labor and Pensions (HELP) Committee.  An overwhelming
bipartisan majority of Senators, including Committee Chair Ted Kennedy
(D, MA), voted for the amendment which will create a strong approval
pathway and includes 12 years of data exclusivity to ensure continued
biomedical innovation.  The amendment passed the Committee by a vote of
16 to 7 with majority support from both Democrats and Republicans.  The
HELP Committee amendment also drew support from a diverse array of
patient groups and other stakeholders including the AIDS Institute,
National Minority AIDS Council, Children=E2=80=99s Tumor Foundation, Nation=
al
Kidney Foundation, and Vietnam Veterans of America.

=E2=80=9CThe amendment approved by the House Energy and Commerce Committee =
today
embodies the bipartisan HELP Committee compromise while retaining the
important provisions of H.R. 1548 aimed at avoiding patient and provider
confusion over biosimilar products and ensuring patent disputes will be
resolved prior to the expiry of the data exclusivity period.

=E2=80=9CToday=E2=80=99s action also is an important vote for our nation=E2=
=80=99s economy and
our global leadership in innovation.  Biotechnology helps drive more
than 7.5 million high-wage, high value jobs across the nation, many of
which have been created by small, highly innovative companies.  More
than 90% of BIO=E2=80=99s research and development member companies have le=
ss
than $25 million in annual revenue and the vast majority of our member
companies have less than 50 employees.

=E2=80=9CBIO thanks Representatives Eshoo, Inslee and Barton for their tire=
less
leadership on this issue, and the many Members of the Energy and
Commerce Committee from both parties who voted for the passage of the
amendment.=E2=80=9D
Upcoming BIO Events

BIO Investor Forum
October 28-29, 2009
San Francisco, CA

Advanced Business Development Course
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=E2=80=99s largest
gathering of the biotechnology industry, along with industry-leading
investor and partnering meetings held around the world.

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--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
Wk: +1.202.332.2671 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.=
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