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Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), Biosimilar to Stelara® Approved by FDA

by Monica Chou; Robert S. Schwartz, Ph.D.
April 23, 2024

According to an April 2024 press release, Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn) was approved by the FDA on April 16 as a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). The companies announced in June 2023 that they had reached a settlement and license agreement with Johnson & Johnson, which granted a license entry date for Selarsdi™ in the U.S. by February 21, 2025.

This is the second Stelara® biosimilar approval.  The first was Amgen’s Wezlana™ (ustekinumab-auub), approved on October 31, 2023 as an interchangeable for all of Stelara®‘s approved indications, which can be marketed no later than January 1, 2025 after a settlement with Johnson & Johnson.

There are at least four other pending aBLAs for proposed Stelara® biosimilars: CT-P43 by Celltrion (accepted June 2023); SB17 by Samsung Bioepis and Sandoz (filing date undisclosed); DMB-3115 by Accord BioPharma (accepted January 2024); and Bmab 1200 by Biocon (filing announced February 2024).

This is Alvotech and Teva’s second biosimilar approval, with their Humira® (adalimumab) biosimilar Simlandi® (adalimumab-ryvk) approved as an interchangeable less than two months ago on February 23, 2024.

There are no pending patent proceedings related to Stelara®.

J&J reported that Stelara® had U.S. sales of about $6.97B in 2023.  For more information on pending aBLAs and biosimilar-related patent disputes, please visit BiologicsHQ.com.

 

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The authors would like to thank April Breyer Menon for her contributions 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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