April Breyer Menon, Author at Venable's BiologicsHQ

Celltrion Files IPR on Regeneron’s EYLEA® Patent

by April Breyer Menon | Jan 22, 2025

On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious. The claims are directed to ophthalmic formulations of a...

Amgen Launches Wezlana™ as the First Stelara® Interchangeable Biosimilar through Optum’s Nuvaila

by April Breyer Menon | Jan 16, 2025

On January 1, 2025, Amgen launched the first interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), Wezlana™ (ustekinumab-auub), as a private label product through Optum Health’s Nuvaila. According to Optum’s formulary,...

Venable’s BiologicsHQ Monthly Injection – December 2024

by April Breyer Menon | Jan 14, 2025

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aBLA Updates: Stelara® Biosimilar Steqeyma™ (ustekinumab-stba) FDA-Approval; Lucentis® Biosimilar Xlucane™ (ranibizumab) aBLA Resubmission

by April Breyer Menon | Jan 7, 2025

On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Celltrion previously reached a settlement agreement allowing Steqeyma™...

Blincyto® Found to Infringe Lindis Biotech’s Patents

by April Breyer Menon | Dec 19, 2024

On December 17, 2024, after a seven-day jury trial in Case No. 1:22-cv-00035 (D. Del.), the jury returned its verdict, finding Lindis Biotech’s U.S. Patent Nos. 8,709,421 (claims 3, 8, and 15) and 10,071,158 (claims 1, 12, and 20) willfully infringed by Amgen’s...

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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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