On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and license agreement allows Biocon to commercialize Bmab 1200, its proposed biosimilar to Stelara® (ustekinumab), in the U.S. by February 2025, subject to FDA approval. This IPR was the last pending biosimilar patent proceeding related to Stelara®.

The press release also noted that the FDA has accepted the aBLA for Bmab 1200 for review. Currently, there are at least four other pending aBLAs for Stelara® biosimilars, including Alvotech and Teva’s AVT04, Celltrion’s CT-P43, Samsung Bioepis’s SB17, and Accord BioPharma’s DMB-3115.

For further discussion of IPR2023-01444, see Stelara® Biosimilar Updates: IPR Petition Challenging U.S. Patent No. 10,961,307 Filed and SB17 Settlement and Launch Date Announced — Venable’s BiologicsHQ.

Stelara® had U.S. sales of $7 billion in 2023.

We continue to monitor this aBLA.  For more information about Stelara® and biosimilar-related patent disputes, please visit



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


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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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