Alfresa Holdings Corporation Opens Up Japan's Biosimilar Market
- A New Challenge in a Government-led Project -

In recent years, biopharmaceuticals have rapidly gathered attention in the global pharmaceutical market. Biopharmaceuticals now make up more than half of the sales among the world’s top 100 best-selling pharmaceutical products, and the market continues to grow significantly.^*1,*2Its demand is expected to increase, because the efficacy is anticipated, especially against autoimmune diseases, cancer, rare diseases, and other conditions.^*3However, biopharmaceuticals are generally high-cost drugs, resulting in a challenge for both governments and patients in healthcare expenditure. Therefore, it is crucial for the general public to have an option of biosimilars^*4which offer equivalent efficacy to originator products at lower drug prices, from the perspective of optimizing healthcare costs and expanding treatment options for patients. Furthermore, biosimilars sold in Japan rely heavily on imports, and the stable domestic supply system should be enhanced as an urgent priority. Consequently, the government is trying to develop the domestic biopharmaceutical industry, including establishing a subsidy program aimed at developing domestic manufacturing bases, to actively promote the use of biosimilars.^*5Under such circumstances, Alfresa Holdings Corporation, Kidswell Bio Corporation, and Chiome Bioscience Inc. take on the challenge of establishing domestic manufacturing bases for biosimilars, supported by grants from the Ministry of Health, Labour and Welfare through “Support Program for the Establishment of Domestic Manufacturing Facilities for Biosimilars.”^*6

We spoke with three members of Alfresa Holdings Corporation who are at the forefront of this government-led project: Mr. Akira Nabeshima, General Manager; Mr. Mitsuru Ishiguro, Deputy General Manager; and Mr. Yoichi Koyanagi, Project Manager, all from the Total Supply Chain Services Platform Business Development Department.

1. *1 References: (Japanese Only) Pharmaceutical Industry Vision Research Centre, PIVRC News No. 64, November 2021, Nationality of companies creating Top-selling pharmaceuticals worldwide - Trends in 2020
2. *2 References: (Japanese Only) Pharmaceutical Industry Vision Research Centre, PIVRC News No.74 March 2025 Nationality of companies creating Top-selling pharmaceuticals worldwide - Trends in 2023
3. *3 References: (Japanese Only) Council for Proper Use of Medicines, “What You Need to Know about Biopharmaceuticals”
4. *4 An equivalent product of the same quality of an original biologic that has already been approved and sold in Japan that is sold by a different pharmaceutical manufacturer following the patent expiration and reexamination period of the original biologic.
5. *5 References: (Japanese Only) Ministry of Health、Labour and Welfare, “Policy for promoting the use of biosimilars”
6. *6 Refer to:Press Release Notice Regarding Selection for Subsidies Under the Ministry of Health, Labour and Welfare Support Program for the Establishment of Domestic Manufacturing Facilities for Biosimilars and Start of a Collaborative Development Project for a Manufacturing Facility

The Robust Collaborative Framework Built by the Four-company Alliance

The Alfresa Group has formulated the “Alfresa Group’s Mid- to Long-Term Vision” as its growth strategy through fiscal year 2032. They leverage the diverse capabilities of the entire group in an integrated and coordinated way. This enables them to enhance and expand their “Total Supply Chain Service,” which establishes a seamless supply chain and provides services from the introduction and development of pharmaceuticals and other products, through manufacturing, logistics, and sales, to post-marketing surveillance and last-mile operations — all delivered as a unified group effort. Their Total Supply Chain Services Platform Business Development Department, where the project is promoted, creates new value within the group and delivers that value as services while also striving to enhance those capabilities by supporting smooth coordination among the Alfresa Group to build and operate the total supply chain services that the Alfresa Group aims for.

The Alfresa Group operates the Manufacturing Business and has established a nationwide distribution network in the Ethical Pharmaceuticals Wholesaling Business. Kidswell Bio Corporation engages in the product development and stable supply of multiple biosimilars. Chiome Bioscience Inc. has long experience in the research and development of antibody therapeutics. In addition to these three corporations, Mycenax Biotech Inc. participates as a key stakeholder in this project, as a contract development and manufacturing organization (CDMO) for biopharmaceuticals in Taiwan with extensive experience and expertise in facility design, manufacturing technology, operations, and human resource development. Together, the four companies are building a collaborative framework that leverages their respective strengths to ensure a stable supply of biosimilars.

This Project Represents an Opportunity to Acquire Key Capabilities for the Total Supply Chain Service

General Manager, Akira Nabeshima expressed his enthusiasm for the project, “We must adopt an end-to-end perspective, designing not only upstream processes such as active pharmaceutical ingredient (API) production and aseptic filling for biosimilars, but also downstream processes including how the products are marketed, distributed, and ultimately delivered to patients. In the Japanese market, the trend shifts from small-molecule drugs to biopharmaceuticals, primarily in the areas of autoimmune diseases, cancer, and rare diseases. We can easily expect that the biosimilar market will expand with the demand for biopharmaceuticals. We regard this national policy project as an important chance to acquire key capabilities for our total supply chain services, and will ensure its success to realize the Alfresa Group’s Mid- to Long-Term Vision.”

Experiencing “Everything Necessary to Deliver New Drugs to Patients” in Singapore

Mr. Koyanagi said, “I find it challenging in this important project aligned with national policy due to its high level of contribution to society”. He has worked abroad for a major pharmaceutical manufacturer in London and Singapore. Especially in Singapore, he has been deeply involved in establishing local subsidiaries and new drug launch projects as the president of a local subsidiary.

He looked back on his past, saying that he had built everything required to sell a drug in a single country from scratch, including establishing a local subsidiary, obtaining regulatory approval, introducing products, negotiating pharmaceutical registrations with authorities, building sales channels, and setting up logistics systems. He added that these experiences are now being applied to this project. “We strive to consistently envision projects with a high viewpoint and a broad perspective, enabling us to oversee the entire product lifecycle. Furthermore, we advance with the grit to persevere, while engaging stakeholders,” he stated emphatically.

“We must align perspectives and coordinate with stakeholders from each company, so that the four-company alliance can promote things smoothly with a brisk pace. Given the diverse technical backgrounds of our collaborative partners, we make it a point to carefully resolve one by one any questions or concerns that arise during communication," he said, showing a sincere commitment to engaging with diverse opinions and challenges.

We, Working Employees, Must Be Vibrant to Realize Our Group Philosophy

Mr. Ishiguro has worked for over 16 years at the Alfresa Group, combining experience in the Ethical Pharmaceuticals Wholesaling Business and the Manufacturing Business. During this time, he has acquired specialized knowledge of pharmaceuticals and developed a broad range of skills in areas such as organizational management and business planning. In this project, he engages in new areas he has never experienced, such as factory design and construction, the launch of new pharmaceutical products, and collaboration with overseas companies.

“Thanks to the knowledge and skills learned through my experience, I can collaborate smoothly with stakeholders and approach tasks from multi-faceted viewpoints. I believe it's important to keep challenging new things, rather than settling for the status quo,” Ishiguro said emphatically.

“To realize our group philosophy of ‘Delivering a fresh life,’ it is essential that we, working within the Alfresa Group, are vibrant. That is exactly why we tackle new challenges” He consistently embraces this project with a positive outlook.

The Biggest Challenge Is to Develop and Secure Specialized Talent

“The biggest hurdle for stable supply of biosimilar products is to develop and secure specialized talent. The highly specialized fields of manufacturing active pharmaceutical ingredients for biopharmaceuticals and aseptic filling face a global shortage of skilled personnel. Our most critical task is to build a stable supply system while advancing human resource development in collaboration with local governments, universities, and partner companies,” says Mr. Koyanagi.

“Regarding human resource development, we need to collaborate closely with our partner companies,” says Mr. Ishiguro, continuing, “There is much to learn here, since this is the first initiative for the Alfresa Group as well. I myself will continue to hone my skills daily, accumulating expertise to foster the development of future leaders.”

“Our dream is to accelerate the development of both facilities and human resources, build a framework for the stable supply of biosimilars, and ultimately enhance the competitiveness of Japan's biopharmaceutical industry,” they both say in unison.

Seeking to Solve the Societal Challenge of a Stable Supply of Biopharmaceuticals

The significance that Alfresa Group participates in the domestic manufacturing of biosimilars, as a national policy, has roots deeply in the Alfresa Group philosophy: “We create and deliver a fresh life for all.”

The Alfresa Group will continuously strengthen and expand its Total Supply Chain Services, providing as a united group everything from the introduction and development of pharmaceuticals and other products, through manufacturing, logistics, and sales, to post-marketing surveillance and last-mile operations. In doing so, the Group aims to achieve sustainable growth while also tackling societal challenges, such as expanding treatment options for patients and improving access to medicines through the stable supply of biopharmaceuticals.

Notice: This document is a translation of the original Japanese document and is for reference purposes only. In the event of any discrepancy between this translated document and the original Japanese document, the latter shall prevail.