Alvotech Secures $50 Million Investment from Fuji Pharma to Enter Japan's Biosimilars Market

Recently, VCBeat (WeChat Official Account: vcbeat) learned from foreign media reports that Icelandic biopharmaceutical company Alvotech announced on December 17 (local time) that Fuji Pharmaceutical of Japan had acquired a 4.2% stake in Alvotech for approximately $50 million.

Alvotech, founded in 2013, is a private biopharmaceutical company dedicated to developing and manufacturing high-quality biosimilars for the global market. The company’s current primary product portfolio comprises six biologic monoclonal antibodies for the treatment of cancer, autoimmune diseases, inflammatory conditions, and other disorders, with its first products expected to launch in 2020.

Fuji Pharmaceutical was established in 1965. It is a Japanese pharmaceutical company listed on the Tokyo Stock Exchange (ticker symbol: TSE), primarily engaged in the manufacturing and sales of prescription drugs. Fuji Pharmaceutical focuses on the development and commercialization of hormonal products for obstetrics and gynecology, as well as injectable drugs, including radiopharmaceuticals. The company also developed a G-CSF biosimilar, which received approval in Japan in 2012.

This November, Alvotech and Fuji Pharma established an exclusive partnership, announcing a sole agreement for the development and commercialization of biosimilars in Japan. Under the agreement, Alvotech is responsible for developing and supplying multiple high-value biosimilar products from its current pipeline, while Fuji Pharma will handle regulatory approval and commercialization of these products in Japan.

This partnership aims to establish a long-term relationship while providing Fuji Pharma with the opportunity to invest in Alvotech’s capital structure. Through this collaboration, Alvotech will gain access to Japan’s rapidly growing biosimilar market, which is projected to achieve a compound annual growth rate (CAGR) of up to 35% compared to the previous year. Meanwhile, Fuji Pharma will leverage its strong local expertise to commercialize Alvotech’s product portfolio in Japan.

This investment by Fuji in Alvotech further strengthens the collaboration between the two companies. Robert Wessman, founder of Alvotech, stated, “Alvotech is a biopharmaceutical company integrating R&D, manufacturing, clinical development, and regulatory affairs. We warmly welcome Fuji Pharma, with its extensive industry experience in the Asia-Pacific region, to join us. Together, we will secure a leading position in Japan’s rapidly growing biosimilar market and deliver high-quality biosimilars to patients worldwide.”

Hirofumi Imai, Chairman of Fuji Pharmaceutical, stated, “Fuji Pharmaceutical is delighted to partner with Alvotech. I firmly believe that Alvotech possesses unique capabilities in the development and manufacturing of biologics. Together, we will ensure that patients in Japan have access to high-quality biosimilars, thereby alleviating the cost burden imposed on Japanese society by its rapidly aging population.”

Biosimilars are legally permitted new copies of original biologic products whose patent protection has expired, demonstrating comparable quality, safety, and efficacy to the reference biologics. Biosimilars may offer lower-cost alternatives to existing biopharmaceutical products, replacing those that have lost exclusivity rights. As biopharmaceutical technologies are increasingly applied in the treatment of conditions such as rheumatism, oncology, and other chronic diseases, industry professionals predict that biologics will soon account for half of all newly approved drugs, thereby driving significant interest within the pharmaceutical sector in the development of biosimilars.

Biosimilar products have received regulatory approval in strictly regulated markets and have been safely used by patients since 2006, with their market share growing at varying rates globally. Alvotech’s biosimilar portfolio comprises high-value products for advanced therapies in oncology, ophthalmology, and autoimmune diseases, sectors whose global sales were estimated to exceed $32 billion in 2017.