Senate HELP Committee Vote Charts Right Course To Biosimilars

WASHINGTON, D.C. (Monday, July 13, 2009) - The following statement was issued by Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood following a vote in the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) on legislation establishing a regulatory pathway for biosimilars:

“Tonight’s vote is a victory for the patients of today and tomorrow who are living with debilitating diseases including cancer, HIV/AIDs, Parkinson’s and a host of rare diseases.  The HELP Committee has taken a critical step forward on the path toward biosimilars.  The approved language strikes the appropriate balance among ensuring patient safety, expanding competition, reducing costs and providing necessary and fair incentives that will provide for continued biomedical breakthroughs.

“Today’s vote also is a vote for our nation’s innovation economy.  Biotechnology helps drive more than 7.5 million high-wage, high value jobs across the nation. 

“With this vote, the HELP Committee has embraced our long held belief that a minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of expanded competition.  More, the vote marks a significant defeat for those who would shortchange future breakthroughs and the hope for cures for some of the most devastating diseases by supporting an abbreviated period of data exclusivity.  Tonight's vote combined with growing support in the House for H.R. 1548 (The Pathway to Biosimilars Act), which now boasts 129 cosponsors, shows strong bipartisan support for at least 12 years of exclusivity.  In contrast, the competing bill, H.R. 1427, has attracted only 13 cosponsors.

"We thank Senators Orrin Hatch (R-UT), Mike Enzi (R-WY) and Kay Hagan (D-NC) for offering the critical amendment, and we thank the bipartisan group of senators such as Senators Barbara Mikulski (D-MD) and Judd Gregg (R-NH) who advocated openly for the amendment. Last, we thank HELP Committee Chairman Ted Kennedy (D-MA) for voting for the amendment, as he has always been a supporter of biotechnology and life sciences."

Upcoming BIO Events

World Congress on Industrial Biotechnology & Bioprocessing
July 19-22, 2009
Montreal, Quebec, Canada 

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.