Alvotech Receives Market Authorization in Japan for Three New Biologic Drugs

Alvotech, a biotech company, announced that Japan's health ministry has granted marketing approval for three new biosimilar drugs developed by the company, including AVT03, AVT05, and AVT06. AVT05 is the first biosimilar for Simponi (golimumab) to receive approval in Japan. The company aims to increase access to high-quality biologic medicines in Japan and meet growing demand for treatment of chronic diseases.

Alvotech (NASDAQ: ALVO), a global biotechnology company, has received marketing approval from Japan's Ministry of Health, Labor and Welfare for three new biosimilar drugs. The approved products include AVT03, a biosimilar to Ranmark® (denosumab), AVT05, the first biosimilar to Simponi® (golimumab), and AVT06, a biosimilar to Eylea® (aflibercept) Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

The approvals mark a significant milestone for Alvotech, which has been expanding its presence in the Japanese market. The company's partnership with Fuji Pharma, established in 2018, has been instrumental in this growth. The partnership includes rights to two additional biosimilar candidates currently under development, bringing the total collaboration to six products Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

The approval of AVT05 is particularly notable as it is the first golimumab biosimilar to receive approval in any major market globally. Golimumab (Simponi) generated approximately $2.3 billion in global sales in 2023, making this a substantial market opportunity for Alvotech Alvotech Announces Marketing Approval in Japan of Three New Biosimilars^[1].

The three newly approved biosimilars target high-value therapeutic areas: oncology (denosumab), rheumatoid arthritis (golimumab), and ophthalmology (aflibercept). 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].

The approval follows Alvotech's successful launch of its Stelara® biosimilar in Japan last year. The company's commercialized products in Japan now total four, with two more in development. The expansion demonstrates effective execution of their partnership strategy announced in 2018 and suggests the company's regulatory pathway and manufacturing capabilities are meeting Japanese standards 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].