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News

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

by Robert S. Schwartz, Ph.D.
November 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 allowing Amgen to launch Wezlana no later than January 1, 2025.

In addition to Wezlana, there are at least two aBLAs pending at the FDA for Stelara biosimilars, including AVT04 filed by Alvotech and Teva (complete response letter received in October 2023), and CT-P43 filed by Celltrion (submitted in June 2023).  If approved, AVT04 can enter the U.S. market no later than February 21, 2025, and CT-P43 can enter the U.S. market no later than March 7, 2025, based on settlement agreements.

For more information about Stelara, Wezlana, and biosimilar-related patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contribution to this article.

    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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