Japan Approves Alvotech’s Denosumab, Golimumab, And Aflibercept Biosimilars

Alvotech, a global biotech company focused on biosimilars, announced that its partner Fuji Pharma Co., Ltd. has received marketing approval in Japan for three new biosimilar medicines. The approvals were granted by the Japanese Ministry of Health, Labor and Welfare for:

AVT03, a biosimilar to Ranmark® (denosumab), approved for the treatment of bone lesions caused by multiple myeloma or metastatic solid tumors.

AVT05, a biosimilar to Simponi® (golimumab), approved for rheumatoid arthritis patients who have not responded adequately to conventional therapies. Based on public data, AVT05 is the first golimumab biosimilar to be authorized in any major global market.

AVT06, a biosimilar to Eylea® (aflibercept), approved for age-related macular degeneration (AMD) with subfoveal choroidal neovascularization, macular edema following retinal vein occlusion, and choroidal neovascularization in pathologic myopia.

“We are thrilled to receive marketing approvals for three additional biosimilars in Japan, after our successful launch last year with Fuji Pharma 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.”

This marks a significant milestone for Alvotech and Fuji Pharma, building on their collaboration that began in 2018. In May 2024, the partners launched the first biosimilar to Stelara® (ustekinumab) in Japan. In addition to these four marketed biosimilars, Fuji Pharma also holds rights to two additional Alvotech biosimilar candidates currently in development.