Alvotech Secures Japanese Approval for Three Biosimilars Including First Global Golimumab Biosimilar
Key Insights
Alvotech's partner Fuji Pharma (search) received Japanese regulatory approval for three biosimilars: AVT03 (denosumab), AVT05 (golimumab), and AVT06 (aflibercept) from the Ministry of Health, Labor and Welfare.
AVT05 represents the first golimumab biosimilar approved for sale in major global markets, marking a significant milestone in biosimilar development.
The approvals expand treatment access for multiple conditions including bone lesions, rheumatoid arthritis, and various eye disorders in the Japanese market.
Alvotech has achieved a significant regulatory milestone in Japan with the approval of three new biosimilars, including what appears to be the world's first golimumab biosimilar approved for major markets. The company's commercialization partner Fuji Pharma (search) Co., Ltd. received marketing approval from the Japanese Ministry of Health, Labor and Welfare for AVT03 (denosumab biosimilar), AVT05 (golimumab biosimilar), and AVT06 (aflibercept biosimilar).
Breakthrough in Golimumab Biosimilar Development
The approval of AVT05 represents a notable first in the biosimilar landscape. Based on publicly available information, this golimumab biosimilar is the first to receive approval for sale in major markets globally, positioning Alvotech at the forefront of this therapeutic area.
AVT05, approved in Japan as GOLIMUMAB BS 50 mg PFS for subcutaneous injection, is a biosimilar to Simponi (golimumab). The treatment is approved for rheumatoid arthritis, including prevention of structural joint damage, in patients who have not sufficiently responded to conventional treatments.
Expanding Treatment Access Across Multiple Therapeutic Areas
The three approved biosimilars address diverse medical conditions across oncology, rheumatology, and ophthalmology:
AVT03 (DENOSUMAB BS 120 mg/1.4 mL) serves as a biosimilar to Ranmark (denosumab), known in other global markets as Xgeva. The treatment is approved for bone lesions due to multiple myeloma or metastases of solid tumors.
AVT06 (AFLIBERCEPT BS 40 mg/mL) provides a biosimilar alternative to Eylea (aflibercept) for several eye conditions. The approval covers treatment of age-related macular degeneration associated with subfoveal choroidal neovascularization, macular edema secondary to retinal vein occlusion, and choroidal neovascularization in pathologic myopia.
Building on Partnership Success
The approvals strengthen the established collaboration between Alvotech and Fuji Pharma (search), which began with their partnership agreement in November 2018. The companies previously achieved success with the launch of Japan's first Stelara (ustekinumab) biosimilar in May 2024.
"We are thrilled to receive marketing approvals for three additional biosimilars in Japan, after our successful launch last year with Fuji Pharma (search) of our biosimilar to Stelara," said Robert Wessman, chairman and CEO of Alvotech. "We look forward to increasing access in Japan to these vital biologic medicines and serve the growing need for quality biologics that can lower the cost of treating patients with chronic diseases."
Strategic Pipeline Development
Beyond the four approved biosimilars, Alvotech has licensed commercial rights in Japan to Fuji Pharma (search) for two additional biosimilar candidates currently under development, indicating continued expansion of their therapeutic portfolio in the Japanese market.
The approvals represent a significant step in Alvotech's global biosimilar strategy, which encompasses eight disclosed biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. The company has established strategic commercial partnerships across multiple regions including the United States, Europe, Japan, China, and other Asian countries.