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PhRMA Statement Supporting Fair Incentives for Biologics Innovation
Date:10/19/2009

have the potential to circumvent patents -- while qualifying for an abbreviated application.

"Economists and the venture capitalists whose private investments shore up this vital, yet vulnerable sector agree: 12 years of data protection, at a bare minimum, are needed to help recoup the significant development costs for biologic innovators. That, however, does not constitute market exclusivity. Companies could still seek approval of competing biologics using their own data, but for those 12 years no biosimilar competitor could rely on innovators' hard-earned data, collected during development that may span a decade, or more, to seek approval.

"For many biologics on the market right now, the 12-year data protection clock began ticking long ago, when federal regulators approved the therapy. In addition to the brand-to-brand competition that already occurs for biologics, those biologic medicines could face biosimilar competitors relatively soon; multiple biosimilars are already on the market in Europe.

"Biosimilar versions of current biologics may well be approved before 12 years have elapsed after the law's enactment, but 12 years of data protection is important to provide incentives for manufacturers to create the next wave of innovative biologics.

"Giving short shrift to incentives for innovation would grind to a halt uniquely American innovation, moving critically important R&D -- and tens of thousands of U.S. jobs -- overseas. Right now, 80 percent of the world's biotech research occurs in the U.S.

"A diverse group of supporters agree with the need for adequate data protection, from patients eagerly awaiting new therapies to elected officials who understand how tenuous U.S. leadership in biologics research could become if incentives for innovation are weakened:

  • 'Many of these biologics will be developed from early-stage discoveries arising from basic research conducted by universities. ..
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SOURCE Pharmaceutical Research and Manufacturers of America
Copyright©2009 PR Newswire.
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