Stelara® Biosimilar Updates: Settlement of IPR and FDA Review of Proposed Biosimilar | Venable LLP
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.
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The authors would like to thank April Breyer Menon for her contributions to this article.
