On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars:
- Golimumab: AVT05 (GOLIMUMAB BS 50 mg PFS for subcutaneous injection), biosimilar to Janssen’s Simponi®;
- Denosumab: AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection), biosimilar to Daiichi Sankyo’s Ranmark®, which is marketed in other countries as Amgen’s Xgeva®; and
- Aflibercept AVT06 (AFLIBERCEPT BS 40 mg/mL solution in PFS for IV injection and 40 mg/mL vial kit for IV injection), biosimilar to Regeneron/Bayer’s Eylea®.
Alvotech considers that the Japanese approval of AVT05 is the first golimumab biosimilar approval in any major market. Alvotech/Fuji’s AVT04, biosimilar to J&J’s Stelara®, was the first ustekinumab biosimilar approved in Japan in September 2023.
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. The agreement covers the four approved biosimilars, plus two unnamed biosimilar candidates currently under development.
In January 2025, Celltrion announced plans to launch its denosumab (CT-P41) and aflibercept (CT-P42) biosimilars in Japan during 2025, together with ustekinumab (CT-P43), omalizumab (CT-P39) and tocilizumab (CT-P47) biosimilars.