#Japan #Biosimilars #Toyama #Cytiva #Yosindo

Cytiva and Yosindo Join Forces to Propel Biosimilar Production in Japan

Cytiva, a global provider of technologies and services for biopharmaceutical manufacturing, and Yosindo Co., Ltd. have recently announced their partnership through a FlexFactory™ agreement. This collaboration aims to bolster the domestic manufacturing framework of biosimilar drug substances specifically tailored for the Japanese market.

Yosindo is set to begin the manufacturing of biosimilar drug substances at its own facility located in Toyama Prefecture starting in 2028. This initiative will play a crucial role in ensuring a stable supply of economically viable biopharmaceuticals across Japan. The newly forged partnership allows Yosindo to utilize single-use technologies for the production of biosimilar drug substances. This grants them the flexibility needed to adapt to future market demands quickly and effectively accelerate the startup of their facilities.

The FlexFactory™ solution offered by Cytiva integrates standardized modular bioprocess design technologies. This innovative approach minimizes the time required from facility design to commercial production, even for those without deep expertise in single-use systems. Through a process design phase scheduled to be completed in early 2026, Yosindo will gain visibility into its manufacturing operations and forecast essential operational requirements.

The facility in question is primarily aimed at producing biosimilar drug substances for antibody pharmaceuticals tailored to the Japanese market. This expansion represents a vital step for Yosindo, building upon a decade of accumulated expertise in biopharmaceuticals. Furthermore, the implementation of the proposed facilities comes with support from Japan's Ministry of Health, Labour and Welfare (MHLW), which provides financial assistance for the construction of domestic manufacturing facilities for biosimilars.

Kenzo Shimomura, Chairman of Yosindo, expressed his enthusiasm about the agreement, stating, "This contract marks a significant milestone in establishing a comprehensive biosimilar manufacturing structure, from raw materials to finished products. Our goal is to build a flexible manufacturing capacity that consistently meets the needs of patients in Japan."

Nick Lines, General Manager of Cytiva Japan, added, "By working closely with Yosindo, we are supporting the implementation of the latest manufacturing approaches. We're accelerating the establishment of facilities for biosimilar production, thereby reinforcing domestic supply resilience."

According to a research report from Fuji Keizai, the biosimilar market in Japan is anticipated to grow from approximately 903 billion yen in 2020 to about 1.24 trillion yen by 2030, representing a 37.5% growth rate. This growth is attributed to the expanding use of biosimilars across major disease areas and initiatives by the MHLW to promote biosimilars to maintain the sustainability of healthcare in Japan. Overall, these market and policy trends present a promising outlook for the stability and growth of the Japanese biosimilar industry over the next decade.

About Yosindo

Founded in 1929, Yosindo has established a robust system for research, development, manufacturing, and sales of generics, gaining a strong reputation for producing high-quality and reasonably priced pharmaceutical products. The company is also focusing on essential drugs such as infusion and dialysis fluids, as well as biopharmaceuticals, aiming to become an indispensable pharmaceutical enterprise in Japan.

About Cytiva

Cytiva's mission is to accelerate the advancement and development of therapeutics. With around 15,000 employees across more than 40 countries, Cytiva leverages its expertise and capabilities to enhance customer flexibility, productivity, and efficiency. Our extensive portfolio of tools and technologies, global reach, and top-tier services provide essential support across a broad spectrum of research and biopharmaceutical manufacturing, from drug discovery to delivery. For more information, visit cytiva.com.

Cytiva is proud to be part of the Danaher scientific innovation family (NYSE: DHR), dedicated to accelerating science and technology in life sciences and diagnostics. Learn more about Danaher at www.danaher.com.