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In an interview with The Center for Biosimilars, Ha Kung Wong discussed the Biologics Price Competition and Innovation Act of 2009 (BPCIA) “patent dance” framework for biosimilar patent proceedings, which helps streamline patent disputes, potentially reducing litigation and encouraging early settlements.  He also discussed ongoing legislative efforts that may impact the biosimilar sector, such as legislation that would limit the number of patents that could be asserted in a patent litigation, The Biosimilar Red Tape Elimination Act, the Patent Eligibility and Restoration Act of 2023, and increased congressional scrutiny of pharmacy benefit managers (PBMs).  Wong answered questions regarding antitrust lawsuits related to biosimilars and combatting patent thickets.

The full interview with The Center for Biosimilars can be found here.


    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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