Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), Biosimilar to Stelara® Approved by FDA | Venable LLP
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.
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The authors would like to thank April Breyer Menon for her contributions to this article.
