April Breyer Menon, Author at Venable's BiologicsHQ

FDA Approves Boehringer Ingelheim’s Cyltezo® as Interchangeable with Humira®

by April Breyer Menon | Oct 25, 2021

On October 15, 2021, the FDA approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) as interchangeable with AbbVie’s Humira® (adalimumab) for many of Humira’s approved indications. As an interchangeable, Cyltezo can be automatically substituted for Humira...

U.S. Patent Legal Landscape Outlook

by April Breyer Menon | Oct 22, 2021

Ha Kung Wong, Wei Campbell, and Christine Cochran gave a LSPN Live presentation titled “US Patent Legal Landscape Outlook: What are the Main Challenges Facing the US Patent System and how do we Prepare for them?” where they discussed recent Supreme...

Venable’s BiologicsHQ Monthly Injection – September 2021

by April Breyer Menon | Oct 12, 2021

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2021 Patent Caselaw Roundup – Lawline CLE

by April Breyer Menon | Oct 11, 2021

Christopher Loh taught a Lawline CLE updating in-house and outside counsel on the latest developments in patent case law. The CLE includes a review of the Supreme Court’s Arthrex decision and its effects on the logistics of inter partes review...

Senator Leahy Introduces the Restoring the America Invents Act, Ending Discretionary Denials at the PTAB

by April Breyer Menon | Sep 30, 2021

On September 29, 2021, Senators Patrick Leahy and John Cornyn introduced the Restoring the America Invents Act in the Senate. According to the Senators, the bill seeks to “address problems for small businesses and ordinary Americans caused by poor-quality patents.” ...

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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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