April Breyer Menon, Author at Venable's BiologicsHQ

VIDEO: FDA and FTC Cooperation to Address Anticompetitive Behavior

by April Breyer Menon | Sep 4, 2018

Ha Kung Wong discusses how the FDA and Federal Trade Commission (FTC) might work together to address anticompetitive behavior in the biosimilars marketplace as part of a video series for the Center for Biosimilars. Transcript: In the Biosimilar Action...

VIDEO: The FDA’s Biosimilar Action Plan

by April Breyer Menon | Aug 30, 2018

Ha Kung Wong discusses key features of the FDA’s Biosimilar Action Plan and potential implications for litigations and inter partes review (IPR) proceedings for biologic drugs as part of a video series for the Center for Biosimilars. Ha Kung...

Venable’s BiologicsHQ Monthly Injection – July 2018

by April Breyer Menon | Aug 3, 2018

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Trends And Predictions For Serial Biologic Drug IPR Petitions

by April Breyer Menon | Jul 31, 2018

Two decisions over the past year could have significant implications in how serial inter partes review petitions are handled by the Patent Trial and Appeal Board going forward. The first, General Plastic Industrial Co. v. Canon Kabushiki Kaisha, which laid out a...

Biosimilars and the Biologics Price Competition and Innovation Act (BPCIA)

by April Breyer Menon | Jul 31, 2018

The Biologics Price Competition and Innovation Act (BPCIA) provides an abbreviated pathway for companies to bring biologic drugs to market that are “biosimilar” to previously approved branded reference products by relying on clinical studies that were performed by the...

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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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