On 22 December 2025, Alvotech announced the European launch of Gobivaz® (AVT05), biosimilar to Janssen’s Simponi® (golimumab), which is the first golimumab biosimilar to be marketed worldwide.
Gobivaz® has been awarded a National Health Service (NHS) England tender and, according to Alvotech, availability across EEA markets will “progress in line with national pricing and reimbursement processes”.
Gobivaz® was approved in Europe and the UK in November 2025 in both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL), with the European MAA for the product being the first golimumab biosimilar MAA to be accepted anywhere in the world in November 2024.
The biosimilar 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. 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, Gotenfia® (BAT2506), is also being developed by Bio-Thera. Gotenfia® received a positive opinion from the EMA’s CHMP in early December 2025 and will be commercialised by STADA in Europe under a May 2024 agreement.