Venable’s BiologicsHQ Monthly Injection – September 2018

by April Breyer Menon | Oct 6, 2018

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VIDEO: Changes to IPRs and PGRs for Biologics

by April Breyer Menon | Oct 4, 2018

Ha Kung Wong addresses recent changes to inter partes review (IPR) and post-grant review (PGR) proceedings with respect to biologic drugs as part of a video series for the Center for Biosimilars. Transcript: What have some of the recent changes to inter...

VIDEO: Biosimilar Manufacturer’s Approach to the Patent Dance

by April Breyer Menon | Sep 25, 2018

Ha Kung Wong discusses how manufacturers now approach the “patent dance” in light of Sandoz v. Amgen as part of a video series for the Center for Biosimilars. Transcript: Have drug makers decided whether is it better for a biosimilar...

VIDEO: The BPCIA 1 Year After Sandoz v. Amgen

by April Breyer Menon | Sep 19, 2018

Ha Kung Wong discusses lessons learned about the Biologics Price Competition and Innovation Act in the year following Sandoz v. Amgen as part of a video series for the Center for Biosimilars. Transcript: It’s been just about 1 year since Sandoz v. Amgen...

VIDEO: The Importation of Biologics and Biosimilars

by April Breyer Menon | Sep 11, 2018

Ha Kung Wong discusses the Trump administration’s proposal to allow importation of drugs, including biologics as part of a video series for the Center for Biosimilars. Transcript: Were there elements of the Trump administration’s blueprint on...

CRISPR-Cas9: Federal Circuit Says No Interference-in-Fact Between University of California and Broad Institute

by April Breyer Menon | Sep 10, 2018

Federal Circuit Affirms PTAB Determination of No Interference-in-Fact Between University of California and Broad Institute over CRISPR-Cas9 Technology On September 10, 2018, Judges Prost, Schall and Moore of the Federal Circuit, in University of California v....

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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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