On 6 November 2026, Bio-Thera Solutions announced that China’s National Medical Products Administration (NMPA) has approved BAT2506, biosimilar to Janssen’s Simponi® (golimumab), which will be marketed under the name 阿舒立® (Ashuli). This is the first golimumab biosimilar to be approved in China.
BAT2506 was also the first (and to date remains the only) biosimilar golimumab approved in the US (in May 2026), where it will be commercialised by Accord BioPharma under the names Immgolis™ (referencing Simponi®) and Immgolis Intri™ (referencing Simponi® Aria). On 30 September 2026, the US District Court for the District of Delaware granted Janssen a preliminary injunction preventing Accord/Bio-Thera from launching Immgolis™ and Immgolis Intri™ in the US during the term of the relevant patent(s). The preliminary injunction was granted in the context of BPCIA proceedings commenced by Janssen against Accord and Bio-Thera on 3 March 2026, alleging that Immgolis™ and Immgolis Intri™ infringe 17 Janssen patents. Accord and Bio-Thera have appealed the injunction decision (which is not yet publicly available), with a Notice of Appeal filed on 1 October 2026.
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.
Bio-Thera has entered commercialisation agreements for BAT2506, including with Intas for Latin America (announced March 2026) and Canada ( announced October 2025), SteinCares for Latin America (announced March 2024) and Dr Reddy’s for South East Asia (announced March 2025).