VIDEO: Upcoming Changes to Biologics Regulation

by | Dec 4, 2018

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

by | Nov 6, 2018

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?...

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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