On 4 November 2025, Fuji Pharma announced that it, and its commercial partner Alvotech, have entered into a settlement and licence agreement with Janssen regarding Golimumab BS (AVT05), biosimilar to Janssen’s Simponi® (golimumab).
Under the terms of the agreement Fuji and Alvotech are granted a licence to market golimumab in Japan, with Golimumab BS Subcutaneous Injection 50 mg Syringe eligible for National Health Insurance price listing and market entry in May 2026.
Alvotech and Fuji Pharma first announced they had entered into a commercialisation agreement for Japan in 2018, with the agreement expanded in February 2022 and January 2023.
AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan. It was also the subject of the first golimumab biosimilar MAA to be accepted anywhere in the world, when the European MAA for AVT05/Gobivaz® was accepted in November 2024. Gobivaz® received a positive CHMP opinion in Europe in September 2025. In the US, AVT05 is being commercialised by Teva. Alvotech/Teva’s BLA for AVT05 was accepted for review by the FDA in January 2025.