Alvotech Announces Marketing Approval of Three New Biosimilars

Alvotech recently announced 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.

“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.”

AVT03, approved in Japan as DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection, is a biosimilar to Ranmark (denosumab), which is marketed in some other countries globally as Xgeva (denosumab). The biosimilar is approved in Japan for treatment of bone lesions due to multiple myeloma or due to metastases of solid tumors.

AVT05, approved in Japan as GOLIMUMAB BS 50 mg PFS for subcutaneous injection, is a biosimilar to Simponi (golimumab). The biosimilar is approved in Japan for treatment of Rheumatoid Arthritis (including prevention of structural joint damage) in patients who have not sufficiently responded to conventional treatments.

AVT06, approved in Japan as AFLIBERCEPT BS 40 mg/mL solution in PFS for IVT injection and 40 mg/mL vial kit for IVT injection, is a biosimilar to Eylea (aflibercept). The biosimilar is approved in Japan 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.

Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com.