On Tuesday, May 23, 2023, Janssen and Amgen settled their case regarding Amgen’s proposed biosimilar to Stelara in Delaware district court.[1]
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.[2] 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.[3] However, the case settled before Amgen filed its answering brief in opposition to the preliminary injunction. The terms of the settlement were not disclosed.
[1] Ord. of Dismissal with Prejudice, 1, Janssen Biotech, Inc., v. Amgen Inc., No. 22-1549-MN (D. Del. May 23, 2023).
[2] See First Amended Complaint ¶ 30, Janssen Biotech, Inc., v. Amgen Inc., No. 22-1549-MN (D. Del. May 23, 2023).
[3] First Amended Complaint ¶¶ 40, 47, Janssen Biotech, Inc., v. Amgen Inc., No. 22-1549-MN (D. Del. May 23, 2023).