Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J.  In February 2023, Formycon announced its entry into a global license agreement with Fresenius Kabi to commercialize FYB202 in key global markets after successful regulatory approvals.  According to the press release, Formycon plans to submit a biologics license application later in 2023 to seek regulatory approval for FBY202.  The settlement permits marketing of FYB202 in the United States, subject to regulatory approval, no later than April 15, 2025.  Economic terms of the settlement were not disclosed in the press release.

In addition, related to ustekinumab biosimilars, we previously reported on Samsung Bioepis’s challenge to all claims of U.S. Patent No. 10, 961,307, assigned to Janssen Biotech, with 34 claims relating to methods for treating ulcerative colitis with ustekinumab.  Janssen Biotech is a subsidiary of J&J.  The parties subsequently filed a joint motion to terminate, supported by a confidential settlement and license agreement and, on August 9, 2023, the USPTO Patent Trial and Appeal Board issued a decision ordering the grant of the joint motion and termination of the proceeding.

This latest settlement follows J&J’s settlement with Amgen regarding ABP 654, pursuant to which Amgen can market its ustekinumab biosimilar in the United States no later than January 1, 2025, as well as J&J’s settlement with Alvotech and Teva regarding AVT04, pursuant to which their ustekinumab biosimilar can be marketed in the United States no later than February 21, 2025, in each case subject to regulatory approval.