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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 h....... Read More


    Federal Judicial Center ? Hot Topics in Patent Litigation
    December 12, 2013

      The Federal Judicial Center recently released a Webinar entitled “Hot Topics in Patent Litigation: Actavis, Hatch-Waxman and the Biosimilars Act.” The Webinar focused on recent developments in areas regarding enforcement of patents in the life science area, generic drugs, and generic biologics. The entire webinar is available here; the following are brief highlights: Hatch-Waxman Patent Settlements: ....... Read More


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