April Breyer Menon, Author at Venable's BiologicsHQ

First Biosimilar and Interchangeable of Stelara® (ustekinumab) Approved in the U.S.

by April Breyer Menon | Nov 5, 2023

On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab). In May 2023, Amgen and Janssen settled their BPCIA lawsuit, with an agreement...

BPCIA Litigation Related to Actemra® Biosimilar Tofidence™ Settles

by April Breyer Menon | Oct 25, 2023

On October 23, 2023, Plaintiffs Genentech, Chugai, and Hoffmann-La Roche and Defendants Biogen and Bio-Thera filed a stipulation of dismissal in Case No. 1:23-cv-11573 (D. Mass.) due to settlement. The BPCIA litigation was filed in July 2023 (complaint), after the...

Venable’s BiologicsHQ Monthly Injection – September 2023

by April Breyer Menon | Oct 16, 2023

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Complimentary Life Sciences Webinar Series

by April Breyer Menon | Oct 6, 2023

We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our seasoned attorneys across various practices who...

New FDA Guidance Removes Interchangeability Statement from Product Labels

by April Breyer Menon | Oct 5, 2023

On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018. According to the FDA, the significant changes from...

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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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