The biosimilars approved for the Japanese market are AVT03, a biosimilar to Ranmark (denosumab), AVT05, a biosimilar to Simponi (golimumab) and AVT06, a biosimilar to Eylea (aflibercept). Based on publicly available information, AVT05 is the first golimumab biosimilar to be approved for sale in major markets globally, states the company.

“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,” says 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.”

In May 2024, Alvotech and Fuji Pharma launched the first biosimilar to Stelara (ustekinumab) in Japan. The partnership agreement between Alvotech and Fuji Pharma was announced in November 2018. In addition to the four approved biosimilars, Alvotech has also licensed commercial rights in Japan to Fuji Pharma for two biosimilar candidates currently under development.