Alvotech Biosimilars Receive Marketing Approval in Japan with Fuji Pharma

Alvotech, a global biotech company, announced that its commercialization partner Fuji Pharma has received marketing approval for three new biosimilars in Japan. The approved biosimilars are AVT03, AVT05, and AVT06, which are biosimilars to Ranmark, Simponi, and Eylea respectively. AVT05 is the first golimumab biosimilar to be approved for sale in major markets globally. The approvals mark a significant milestone for Alvotech and Fuji Pharma in expanding access to biosimilars in Japan.

Reykjavik, Iceland — Alvotech (NASDAQ: ALVO), a global biotech company, announced that its commercialization partner Fuji Pharma Co., Ltd. has received marketing approval for three new biosimilars in Japan from the Japanese Ministry of Health, Labor and Welfare. The approved biosimilars are AVT03, AVT05, and AVT06, which are biosimilars to Ranmark, Simponi, and Eylea, respectively. Notably, AVT05 is the first golimumab biosimilar to be approved for sale in major markets globally Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

AVT03, a biosimilar to denosumab, is approved in Japan for the treatment of bone lesions due to multiple myeloma or metastases of solid tumors. AVT05, a biosimilar to golimumab, is approved for the treatment of rheumatoid arthritis, including prevention of structural joint damage, in patients who have not responded sufficiently to conventional treatments. AVT06, a biosimilar to aflibercept, is approved for the treatment of age-related macular degeneration, macular edema secondary to retinal vein occlusion, and choroidal neovascularization in pathologic myopia Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

The approvals mark a significant milestone for Alvotech and Fuji Pharma in expanding access to biosimilars in Japan, one of the world's largest pharmaceutical markets. These approvals follow the successful launch of Alvotech's Stelara® biosimilar in Japan last year and further demonstrate the effectiveness of their partnership strategy announced in 2018 Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

The simultaneous approval of three biosimilars—one for oncology, one for rheumatoid arthritis, and one for ophthalmology—substantially broadens Alvotech's commercial portfolio in Japan. This diversified approach helps mitigate risk across multiple therapeutic categories while addressing chronic conditions with substantial patient populations in Japan's aging demographic Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

Alvotech's announcement represents a significant milestone in the company's expansion strategy in Japan. The approvals are a testament to the company's regulatory pathway and manufacturing capabilities, which are meeting Japanese standards, known for being among the most stringent globally Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

For biosimilar manufacturers, gaining regulatory approval is the critical hurdle to commercialization. With these approvals secured, Alvotech is positioned to help address Japan's growing need for cost-effective biologics for chronic disease management while generating new revenue streams in this key market Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].