Celltrion Stelara (Ustekinumab) Settlement With J&J

It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to launch the product in the U.S. market on March 7, 2025, if approved by FDA.

This settlement follows prior J&J ustekinumab settlements with:  (1) Amgen, pursuant to which Amgen can market its ustekinumab biosimilar (ABP 654), in the United States no later than January 1, 2025, subject to regulatory approval; (2) Alvotech and Teva, pursuant to which they can market their ustekinumab biosimilar (AVT04) in the United States no later than February 21, 2025, subject to regulatory approval; and (3) Formycon and Fresenius Kabi regarding their ustekinumab biosimiar (FYB202), for which no entry date is publicly available.  J&J also recently filed a confidential settlement and license agreement to terminate a Samsung Bioepis challenge to all claims of U.S. Patent No. 10,961,307, which claims methods of treating ulcerative colitis with ustekinumab.