Alvotech Receives Marketing Approval in Japan for Three Biosimilars
Alvotech's partner Fuji Pharma has secured marketing approval from Japanese authorities for three new biosimilars. The approvals cover treatments for bone diseases, rheumatoid arthritis, and eye conditions.
Reykjavik, Iceland – Biotechnology company Alvotech announced on September 19, 2025, that its Japanese commercialization partner, Fuji Pharma Co., Ltd., has obtained marketing approval from the Japanese Ministry of Health, Labour and Welfare for three new biosimilar medicines.
The approvals are for AVT03 (denosumab, a biosimilar to Ranmark®), AVT05 (golimumab, a biosimilar to Simponi®), and AVT06 (aflibercept, a biosimilar to Eylea®). According to publicly available information, AVT05 is the first golimumab biosimilar to receive marketing approval in major global markets.
These approved medicines are intended for the treatment of various chronic conditions. AVT03 is approved for treating bone lesions due to multiple myeloma or bone metastases from solid tumors. AVT05 is indicated for rheumatoid arthritis, including preventing structural joint damage in patients with an insufficient response to conventional therapies. AVT06 is approved for age-related macular degeneration and other retinal diseases.
The partnership between Alvotech and Fuji Pharma in Japan began in November 2018. Last year, in May 2024, the partners launched the first biosimilar to ustekinumab (a substitute for Stelara®) in Japan. Alvotech also has two other biosimilar candidates under development in Japan, with commercial rights licensed to Fuji Pharma.
Alvotech develops and manufactures biosimilar medicines aimed at improving patient access to treatments and reducing healthcare costs globally. The company's development pipeline includes eight biosimilar candidates across various therapeutic areas.