On 19 June 2026, Janssen filed a BPCIA complaint against Alvotech in the US District Court for the Eastern District of Virginia alleging that Alvotech’s golimumab biosimilars, AVT05 SC and IV, infringe 14 Janssen patents relating to Simponi® (SC), Simponi Aria® (IV) and the manufacture and delivery of biologic products like golimumab.
The proceedings follow 2 weeks after Alvotech announced on 4 June 2026 that it had resubmitted its AVT05 BLA to the FDA. Janssen alleges that by submitting its BLA for AVT05 SC and AVT05 IV and “taking concrete steps to market those products, Alvotech has infringed, and threatens to infringe, Janssen’s patents”.
Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025. Alvotech received a Complete Response Letter from the FDA in November 2025 and subsequently undertook a “remediation project”. The golimumab BLA was then resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility in May 2026 and the provision by Alvotech of responses to observations raised as a result of that inspection. AVT05 will be commercialised in the US by Teva under an August 2020 strategic partnership.
The litigation against Alvotech is the second BPCIA proceeding regarding golimumab commenced by Janssen, following a complaint filed against Bio-Thera Solutions and Accord BioPharma in March 2026. That complaint alleges that Bio-Thera/Accord’s golimumab biosimilars (Immgolis™ and Immgolis Intri™ (BAT2506)), the first and only golimumab biosimilars to have been FDA-approved (May 2026), infringe 17 Janssen patents.
AVT05 was the first golimumab biosimilar to be approved worldwide in September 2025, with its approval in Japan as Gobivaz®. Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.