On 30 September 2026, the US District Court for the District of Delaware granted Janssen a preliminary injunction preventing Accord Biopharma and Bio-Thera Solutions from launching Immgolis™ and Immgolis Intri™ (BAT2506), biosimilars to Janssen’s Simponi® and Simponi Aria® (golimumab), in the US. The reasons for the Court’s decision are not yet publicly available.
Accord and Bio-Thera have appealed the decision, with a Notice of Appeal filed on 1 October 2026.
Janssen originally commenced BPCIA proceedings against Accord and Bio-Thera on 3 March 2026, alleging that Accord/Bio-Thera’s (Immgolis™ and Immgolis Intri™ (BAT2506)) infringe 17 Janssen patents, relating to anti-TNF antibodies, manufacturing methods applicable to biologic drugs (including cell culture processes) and methods of treating ankylosing spondylitis and psoriatic arthritis with golimumab.
Janssen’s allegations regarding 4 method of treatment patents (11,014,982, 11,041,020, 12,122,824, 12,291,566) were subsequently dismissed by consent. Accord and Bio-Thera filed petitions for inter partes review (IPR) of those 4 Janssen method of treatment patents on 20 March 2026 (IPR2026-00256, IPR2026-00257, IPR2026-00258, IPR2026-00259). The IPRs were instituted by the Patent Trial and Appeal Board on 9 September 2026.
Janssen has also commenced BPCIA proceedings against Alvotech (19 June 2026), alleging Alvotech’s AVT05 (golimumab) infringes 14 patents. Teva, Alvotech’s US commercialisation partner, was granted leave to intervene in the proceeding and has filed an application seeking a declaratory judgment of non-infringement and invalidity in relation to the 14 asserted patents.
Janssen filed a motion for preliminary injunction against Alvotech on 29 July 2026, arguing Alvotech infringes US 10,421,986, relating to a high cell density harvesting process. The preliminary injunction hearing is to be scheduled for a date on or after 30 October 2026.
Immgolis™ and Immgolis Intri™ are the first and only golimumab biosimilars to have been FDA-approved (May 2026). Alvotech resubmitted its BLA for AVT05 to the FDA in June 2026 after receiving a complete response letter in November 2025.