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FDA Releases First "Purple Book" for Biosimilar Products
October 01, 2014

The Biosimilars Act (BSA) was passed into law on March 23, 2010 with the goal of encouraging the market entry of generic products, similar to the system that exists for generic drugs under the Hatch-Waxman Act. The BSA sets forth an abbreviated approval pathway for biologics through a regulatory demonstration of biosimilarity (i.e. interchangeability).

More than 4 years after the BSA went into effect, the FDA has released its "Purple Book" listing biological products, including any biosimilar and interchangeable biological products licensed by FDA. The Purple Book is intended to serve a similar function to the "Orange Book" that lists drug products with therapeutic equivalence evaluations that have been approved by the FDA. The release of the Purple Book follows closely behind the filing of the first two applications for approval of biosimilar products.

For more information about the BSA, see the June 2014 issue of MVS Briefs, available here.

More information on the "Purple Book"—including current lists of licensed biological products— is available from the FDA website here.

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