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Expert Analysis

2015 Will Be A Watershed Moment For Biosimilars

Law360, New York (February 3, 2015, 3:07 PM EST) -- The Biologics Price Competition and Innovation Act, enacted as a subsection of the Affordable Care Act and signed into law in March 2010, was designed to create an abbreviated pathway for U.S. Food and Drug Administration approval of biosimilar biologic drugs.[1] Such an abbreviated pathway had existed since 1984 for generic small-molecule drugs via the Hatch-Waxman Act,[2] but the BPCIA broke new ground for large-molecule, complex biologics....

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