On 20 March 2026, Accord BioPharma, Intas Pharmaceuticals and Bio-Thera Solutions together filed four petitions for Inter Partes Review of Janssen’s US patent numbers 12,291,566 (IPR2026-00259), 12,122,824 (IPR2026-00258), 11,041,020 (IPR2026-00257) and 11,014, 982 (IPR2026-00256) in respect of methods of treatment using Simponi®/Simponi Aria® (golimumab).
The challenged patents are 4 of 17 patents asserted against Bio-Thera and Accord in BPCIA litigation commenced by Janssen in the US District Court for the District of Delaware on 3 March 2026. In the US litigation, Janssen’s Complaint (published in redacted form on 11 March 2026) alleges that, by submitting an abbreviated Biologics Licence Application (aBLA) for BAT2506 to the FDA (which was accepted for review in July 2025), and “taking concrete steps to commercially market” the product, Bio-Thera and Accord have infringed and threatened to infringe Janssen’s patents. Janssen is seeking a preliminary injunction (PI) in relation to 1-3 of the asserted patents and has proposed a hearing date for the PI of August/September 2026.
Bio-Thera entered into an exclusive US commercialisation and licence agreement regarding BAT2506 (golimumab) with Intas Pharmaceuticals, announced on 10 February 2025. Under the agreement, Intas Pharmaceuticals’ subsidiary Accord BioPharma is responsible for commercialising the product in the US, while Bio-Thera retains responsibility for development, manufacturing and supply of BAT2506. Bio-Thera received an upfront payment of US$21 million and will receive further development and commercial milestone payments of up to US$143.5 million.
BAT2506 was approved in Europe, under the name Gotenfia®, in February 2026. Gotenfia® is being commercialised in Europe by STADA under a May 2024 agreement. It was the second golimumab biosimilar to be approved in Europe, following the approval of Alvotech/Advanz’s Gobivaz® (AVT05) in November 2025.
Alvotech received a Complete Response Letter (CRL) from the FDA in relation to its US regulatory application for AVT05 (golimumab). According to Alvotech, it is on track to resubmit its application in the first half of 2026. AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020.