Janssen and Amgen Settle STELARA (Ustekinumab) BPCIA Litigation

We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Janssen patents, and about Janssen seeking a preliminary injunction to block Amgen from the commercial manufacturing, sale, and offer for sale of its ustekinumab product.  Briefing for the PI motion was to be completed by July 21, 2023, and a hearing was scheduled for August 4, 2023.  On May 22, 2023, prior to the filing of Amgen’s opposition brief in the preliminary injunction proceedings (due the same day), Janssen and Amgen filed a Stipulation and [Proposed] Order of Dismissal with Prejudice indicating that the parties have agreed to settle the litigation and dismiss the action with prejudice.