VIDEO: Upcoming Changes to Biologics Regulation

Ha Kung Wong discusses how upcoming changes to the regulation of biologics are generating industry uncertainty as part of a video series for the Center for Biosimilars.     Transcript: By 2020, some products that are currently regulated as drugs, like...

VIDEO: Noteworthy Ongoing Biosimilar Litigation

Ha Kung Wong addresses ongoing biosimilar cases that stakeholders are watching closely as part of a video series for the Center for Biosimilars.     Transcript: Are there some ongoing cases that biosimilar stakeholders are watching closely at the moment?...

VIDEO: Changes to IPRs and PGRs for Biologics

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: The BPCIA 1 Year After Sandoz v. Amgen

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

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...

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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