Alvotech Receives Marketing Approval In Japan For Three New Biosimilars

(RTTNews) - Luxembourg-based biotechnology company Alvotech SA (ALVO) announced Friday that its commercialization partner in Japan, Fuji Pharma Co., Ltd. has received marketing approval for three new biosimilars from the Japanese Ministry of Health, Labor and Welfare.

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.

AVT03 is approved in Japan for treatment of bone lesions due to multiple myeloma or due to metastases of solid tumors.

AVT05 is approved in Japan as GOLIMUMAB BS 50 mg PFS for subcutaneous injection for treatment of Rheumatoid Arthritis in patients who have not sufficiently responded to conventional treatments.

AVT06 is approved in Japan as AFLIBERCEPT BS 40 mg/mL solution in PFS for IVT injection and 40 mg/mL vial kit for IVT injection, for treatment of Age-related Macular Degeneration associated with subfoveal choroidal neovascularization, Macular Oedema secondary to retinal vein occlusion and choroidal neovascularization in pathologic myopia.

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.