House Energy and Commerce Committee Vote Marks Another Step Forward on Pathway to Biosimilars

WASHINGTON, D.C. (July 31, 2009) - Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement on the overwhelming approval by a vote of 47 to 11 of an amendment to create a regulatory pathway for biosimilars by the House Energy and Commerce Committee in today’s mark-up of the America’s Affordable Health Choices Act (H.R. 3200):

“The 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.

“The amendment incorporates the principles of H.R. 1548, the Pathway 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’s Tumor Foundation, National Kidney Foundation, and Vietnam Veterans of America.

“The 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.

“Today’s action also is an important vote for our nation’s 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’s research and development member companies have less than $25 million in annual revenue and the vast majority of our member companies have less than 50 employees.

“BIO thanks Representatives Eshoo, Inslee and Barton for their tireless 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.”

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’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.