Commentary: A Competitive Marketplace for Biosimilars

by April Breyer Menon | May 5, 2020

On March 9, 2020, FDA and the US Federal Trade Commission (FTC) held a public workshop to discuss issues related to biosimilars in the United States. According to FDA and FTC, the workshop’s purpose was to discuss the “FDA and FTC’s collaborative efforts to support...

Wong Discusses Strength of Regulatory Actions

by April Breyer Menon | Apr 23, 2020

Venable partner Ha Kung Wong discussed with the Center for Biosimilars recent regulatory actions to promote biosimilars, including the recent FDA/FTC collaboration to fight anticompetitive practices for biosimilars, and the March 23, 2020 transition of regulation of...

Venable’s BiologicsHQ Monthly Injection – March 2020

by April Breyer Menon | Apr 8, 2020

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IAM Quotes Christopher Loh on What the Current Wave of Biosimilar Litigation Signals for the Future

by April Breyer Menon | Mar 16, 2020

In the Spring 2020 edition of IAM, Christopher Loh was quoted on what the current wave of biosimilar litigation signals for the future. According to the article, the substantial increase in patent litigation involving biosimilar drugs over the past few years has...

Venable’s BiologicsHQ Monthly Injection – February 2020

by April Breyer Menon | Mar 12, 2020

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FDA Updates Relating to Biosimilars

by April Breyer Menon | Feb 29, 2020

February was a busy month for the FDA in the field of biosimilars: On February 3, 2020, the FDA and FTC issued a joint statement regarding their enhanced collaboration to support the adoption of biosimilars and interchangeables. On February 3, 2020, the FDA...

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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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