On 20 November 2025, Alvotech and Advanz Pharma announced that the European Commission has granted marketing authorisations in the European Economic Area for Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab). The approval covers both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL) of Gobivaz® for treating adults with rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis, and ulcerative colitis, and for treating juvenile idiopathic arthritis in children 2 years of age and older in combination with methotrexate.
Gobivaz® is being commercialised by Advanz in the UK and Europe under a May 2023 licence and supply agreement with Alvotech, which is responsible for development and commercial supply of the product.
AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma. Also in September 2025, Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after Alvotech/Advanz’s European MAA for that product was the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024. Gobivaz® was approved in the UK in November 2025.
In the US, Alvotech/Teva’s Biologics License Application (BLA) for AVT05 was accepted by the FDA in January 2025. The FDA issued a Complete Response Letter in relation to the BLA in early November 2025, with Alvotech working to resolve “certain deficiencies” identified following a manufacturing facility inspection.
A golimumab biosimilar, BAT2506, is also being developed by Bio-Thera, with an MAA for the product accepted in Europe in February 2025 (where it is being commercialised by STADA under a May 2024 agreement), and a BLA accepted for FDA review in July 2025 (with Accord responsible for US commercialisation). Bio-Thera has entered into commercialisation agreements for BAT2506 with SteinCares for Latin America (March 2024) and Dr Reddy’s for South East Asia (March 2025).