April Breyer Menon, Author at Venable's BiologicsHQ

Ha Kung Wong and April Breyer Menon Discuss Promising and Not-so-Promising Biosimilar Legislation

by April Breyer Menon | Jun 4, 2020

In an extended interview with the Center for Biosimilars, Venable’s Ha Kung Wong and April Breyer Menon discussed potential biosimilars legislation, including the Hatch-Waxman Integrity Act, Stop STALLING Act, Biologic Patent Transparency Act, Affordable and...

April Breyer Menon Discusses 2 Potential Bills to Aid Biosimilar Uptake

by April Breyer Menon | May 28, 2020

It’s no secret that the US biosimilar industry has had a slow start in terms of uptake. Although the Hatch-Waxman Act and the Biologic Price Competition and Innovation Act (BPCIA) established pathways to approval for both generic drugs and biosimilars, there is still...

After Finding a Virus Vaccine, the Challenge Is Making Enough

by April Breyer Menon | May 28, 2020

Venable Fizpatrick partner Ha Kung Wong spoke with Bloomberg Law for an article about regulatory and logistical challenges to approval, manufacturing, and distribution of a new COVID-19 vaccine, including building multiple manufacturing facilities and having them...

Venable’s BiologicsHQ Monthly Injection – April 2020

by April Breyer Menon | May 6, 2020

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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...

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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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