By-Lined Article
Biosimilars--Faster Development and Approval?
By Siegfried J.W. Ruppert, Ph.D.
March 2011
INNsight
Special counsel Siegfried Ruppert, Ph.D., of Duane Morris' Intellectual Property Practice Group in its San Francisco office, reviews the central provisions of the Biologics Price Competition and Innovation Act of 2009, a subsection of the Patient Protection and Affordable Care Act. The Biosimilars Act provides a framework for the approval process of biosimilar biological products, very large, complex proteins made in living cells that are expensive and inherently difficult to manufacture identically. Among other provisions, the law provides 12 years of data exclusivity for innovators -- the U.S. Food and Drug Administration will not allow another manufacturer to rely on the data of an innovator to support approval of a biosimilar product.
Ruppert also outlines a plan in President Obama's FY 2012 budget proposal designed to give consumers more access to affordable pharmaceuticals by reducing the exclusivity period for innovator biologics and prohibiting anti-competitive "pay-for-delay" agreements intended to keep generic products off the market. The result of the proposal, if enacted, would be increased competition between large pharmaceutical firms manufacturing innovator biologics products and biosimilar companies.
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