On Tuesday, May 23, 2023, Janssen and Amgen settled their case regarding Amgen’s proposed biosimilar to Stelara in Delaware district court.
Stelara, also known as ustekinumab, is an anti-IL-12/IL-23 antibody drug used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Amgen has created a biosimilar of Stelara called ABP 654, which has the same amino acid sequence as ustekinumab. Amgen reportedly is conducting clinical studies to support interchangeability of ABP 654 with Stelara. Janssen filed their complaint in November of 2022.
Prior to settlement, the parties were in the midst of completing briefing for a preliminary injunction hearing, initiated by Janssen in an attempt to prevent Amgen from launching their biosimilar product. According to the amended complaint, Amgen provided its Section 8A 180-day notice of commercial marketing on November 7, 2022, and disclosed its aBLA to Janssen in early December 2022. However, the case settled before Amgen filed its answering brief in opposition to the preliminary injunction. The terms of the settlement were not disclosed.
 Ord. of Dismissal with Prejudice, 1, Janssen Biotech, Inc., v. Amgen Inc., No. 22-1549-MN (D. Del. May 23, 2023).
 See First Amended Complaint ¶ 30, Janssen Biotech, Inc., v. Amgen Inc., No. 22-1549-MN (D. Del. May 23, 2023).
 First Amended Complaint ¶¶ 40, 47, Janssen Biotech, Inc., v. Amgen Inc., No. 22-1549-MN (D. Del. May 23, 2023).