April Breyer Menon, Author at Venable's BiologicsHQ

Alvotech and Teva Announce First FDA Acceptance of aBLA for Simponi® / Simponi Aria® (golimumab) Biosimilar

by April Breyer Menon | Jan 29, 2025

On January 27, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT05, a proposed biosimilar of Janssen’s Simponi® / Simponi Aria® (golimumab). This is the first publicly announced acceptance of an aBLA of a golimumab biosimilar. According to a...

Celltrion and Amgen Reach Settlement in Prolia® / Xgeva® Biosimilar Litigation

by April Breyer Menon | Jan 28, 2025

On January 24, 2025, Amgen announced it had reached a settlement with Celltrion in Case No. 1:24-cv-06497 (D.N.J.) related to Celltrion’s proposed biosimilar of Prolia® / Xgeva® (denosumab), CT-P41. The lawsuit involved allegations of infringement of 29 of...

FDA Approves Third Actemra® Biosimilar, Celltrion’s Avtozma® (tocilizumab-anoh)

by April Breyer Menon | Jan 26, 2025

On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab). Avtozma® is indicated for the treatment of multiple diseases...

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,...

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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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