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Biosimilar Experts Give Highlights of US Uptake Issues

by Ha Kung Wong
May 23, 2019

Venable partner Ha Kung Wong spoke at the ISPOR 2019 annual meeting as part of a panel that reviewed the current state of the biosimilar market and challenges to biosimilar uptake in the U.S.  His comments on pending Congressional action relating to the Purple Book, including the “Purple Book Continuity Act of 2019” in the House of Representatives and the “Biologic Patent Transparency Act” in the Senate, were included in an article in The American Journal of Managed Care (AJMC).  The article can be viewed 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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