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The Biosimilars Litigation Landscape For 2017

Law360, New York (January 6, 2017, 5:16 PM EST) -- Michael B. Cottler

Joshua A. Whitehill In 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Affordable Care Act. The BPCIA established an abbreviated regulatory pathway for biosimilars and unique litigation mechanisms for resolving patent disputes between biosimilar applicants and reference product sponsors (RPSs).

In practice, a new BPCIA complaint stems from the U.S. Food and Drug Administration acceptance of a biosimilar application filed under subsection (k) of the BPCIA (i.e., an “abbreviated Biologics License Application,” or “aBLA”), which triggers a cascade of exchanges between the applicant and RPS that is commonly...

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