Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA.  The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval.  As part of the settlement, Biocon has agreed to terminate the pending inter partes review of Janssen and J&J’s U.S. Patent No. 10,961,307, which claims methods of treating ulcerative colitis with ustekinumab.

As we have previously reported, Janssen and J&J have reached ustekinumab settlements with Amgen, Alvotech and Teva, Formycon and Fresenius Kabi, and Celltrion.  Amgen secured a U.S. entry date for its ustekinumab biosimilar, WEZLANA, of January 1, 2025, and in October 2023, the FDA approved WEZLANA as biosimilar to and interchangeable with STELARA.