CBO Savings Estimate for Follow-On Biologics Underscores Need for Congress to Move Quickly to Create Pathway for Follow-On Biologics

Business Wire, June 25, 2008

WASHINGTON -- Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood released the following statement regarding the Congressional Budget Office (CBO) report issued today projecting cost savings from S. 1695, the Biologics Price Competition and Innovation Act of 2007:

"The CBO report shows that developing a pathway to review and approve follow-on biologics will result in cost savings to public and private purchasers of biologic products over a ten year period. The report finds that most of the savings will be obtained several years after a follow-on pathway is established, reinforcing the need for Congress to develop and pass a responsible pathway this year that protects patient safety and preserves innovation. We are essentially leaving money on the table the longer we wait to implement a pathway.

"By relying on the provisions in S. 1695, the CBO study also shows that we can achieve meaningful cost savings in biologics spending while providing needed protections to allow for continued innovation. H.R. 1956, the Patient Protection and Innovative Biologic Medicines Act of 2007; H.R. 5629, the Pathway for Biosimilars Act; and S. 1695 all come close to striking this necessary balance.

"Notably, the CBO study projects savings in-line with the estimates from the studies we, unlike others, have continued to reference, including those conducted by Avalere Health and by a research team led by Professor Henry Grabowski of Duke University.

"While follow-on biologics will provide real savings in the aggregate to the government and consumers, the estimated savings will constitute 0.065% of total healthcare spending over the next ten years. Therefore, Congress must ensure proper incentives for continued biomedical innovation in any follow-on biologics pathway so that we don't achieve relatively minor savings as a percentage of overall health care spending at the cost of continued innovation.

"BIO will continue to encourage the House and Senate to consider and pass legislation to create a pathway for the approval of follow-on biologics which protects patient safety and provides incentives for continued innovation."

The CBO cost estimate is available at http://www.cbo.gov/ftpdocs/94xx/doc9496/s1695.pdf.> 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 annual BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. www.bio.org

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