VIDEO: Upcoming Patent Litigation in Biosimilars

by April Breyer Menon | Dec 12, 2017

Ha Kung Wong, Amanda Forys, and Angus Worthing discuss upcoming litigation that affects biosimilars stakeholders as part of the The Center for Biosimilars™ Peer Exchange®. Ha Kung Wong has extensive experience litigating a wide variety of...

VIDEO: The Need for Clarity After Sandoz v. Amgen

by April Breyer Menon | Dec 11, 2017

Ha Kung Wong, Amanda Forys, and Angus Worthing highlight unanswered questions surrounding the Supreme Court’s ruling in Sandoz v. Amgen, which reviewed procedural issues under the Biologics Price Competition and Innovation Act (BPCIA), as part of the The Center for...

Venable’s BiologicsHQ Monthly Injection – November 2017

by April Breyer Menon | Dec 5, 2017

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VIDEO: The PTAB’s Role in Biosimilar Patent Disputes

by April Breyer Menon | Dec 5, 2017

Ha Kung Wong and Amanda Forys provide an overview of the Patent Trial and Appeal Board’s role in patent disputes over biologics, as part of The Center for Biosimilars™ Peer Exchange®. Ha Kung Wong has extensive experience litigating a wide variety...

VIDEO: State Laws and Biosimilar Substitution

by April Breyer Menon | Dec 4, 2017

Ha Kung Wong, Molly Burich, Amanda Forys, and Angus Worthing discuss reactions surrounding the enactment of state laws concerning the eventual substitution of interchangable biosimilars for reference products as part of The Center for Biosimilars™ Peer Exchange®....

Supreme Court Hears Oral Argument On Constitutionality Of Inter Partes Review In Oil States

by April Breyer Menon | Nov 28, 2017

On November 27, 2017, the Supreme Court heard oral argument in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, No. 16-712. The Supreme Court’s decision in this case will either spare or strike down inter partes review as a means for challenging 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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