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Wong Discusses Strength of Regulatory Actions

by Ha Kung Wong
April 23, 2020

Venable partner Ha Kung Wong discussed with the Center for Biosimilars recent regulatory actions to promote biosimilars, including the recent FDA/FTC collaboration to fight anticompetitive practices for biosimilars, and the March 23, 2020 transition of regulation of certain small molecule drugs, including insulins, to regulation as biologics.  He addressed the questions:

  • Will manufacturers be motivated to bring products to market under the newly established biologics approval pathway under the Biologics Price Competition and Innovation Act?
  • Is it possible that the newly announced FDA/Federal Trade Commission (FTC) collaboration to fight anticompetitive practices will improve the marketplace for biosimilars?

View the article by the Center for Biosimilars with his comments 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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