Senate HELP Committee Vote Charts Right Course To 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."
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