On 16 September 2026, Fuji Pharma announced that it has obtained marketing approval in Japan for Golimumab BS 50 mg autoinjector for subcutaneous injection (AVT05), biosimilar to Janssen’s Simponi® (golimumab), and Ustekinumab BS 130 mg intravenous infusion (AVT04), biosimilar to Janssen’s Stelara® (ustekinumab).
Fuji Pharma is Alvotech’s commercialisation partner in Japan for both products. 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.
Biosimilar Golimumab
Fuji already markets a pre-filled syringe presentation of the golimumab biosimilar (AVT05) in Japan, which was approved in September 2025 as Gobivaz®, the first biosimilar golimumab approved worldwide. Gobivaz® was launched in Japan in May 2026 and remains the only biosimilar golimumab on the Japanese market. Under a settlement agreement entered with Janssen in November 2025, the autoinjector form of AVT05 will be eligible for National Health Insurance (NHI) drug price listing and commercial launch in Japan from May 2027.
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. In June 2026, Alvotech resubmitted its BLA for AVT05 to the FDA after receiving a complete response letter, and was then sued for patent infringement in BPCIA litigation commenced by Janssen on 19 June 2026.
Accord BioPharma’s Immgolis™ and Immgolis Intri™ were the first golimumab biosimilars approved in the US in May 2026, although their launch date is uncertain given ongoing BPCIA litigation commenced by Janssen against Accord/Bio-Thera in March 2026.
Biosimilar Ustekinumab
Alvotech/Fuji Pharma’s biosimilar ustekinumab was first approved in Japan in September 2023 and launched in May 2024 in 45 mg and 90 mg subcutaneous formulations. The newly approved ustekinumab biosimilar for intravenous (IV) administration expands Fuji’s portfolio, enabling it to provide treatment options covering both induction and maintenance therapy for moderately to severely active Crohn’s disease.
Fuji is aiming for NHI drug price listing and launch of its IV ustekinumab biosimilar in November 2026.
Fuji Pharma’s IV ustekinumab approval follows Samsung Bioepis/Nipro’s Ustekinumab BS Intravenous Infusion, which was approved in Japan earlier in September 2026, and Celltrion’s IV formulation of Steqeyma® (ustekinumab), which was approved in Japan in April 2026 and launched in August 2026. Subcutaneous ustekinumab biosimilars already launched in Japan include those of Biocon/Yoshindo (May 2025), Celltrion (July 2025), and Samsung Bioepis (May 2026).