研究

International Regulatory Science Forum 2025
Developing Biosimilars: Challenges and Perspectives
The School of Pharmacy, College of Medicine, National Taiwan University hosted the 2025 International Regulatory Science Forum on March 21–22, 2025. Co-organized by the University of Southern California; the Taiwan Society of Regulatory Affairs for Medical Products, the Pharmaceutical Society of Taiwan, and the Ching-Kang Foundation for Pharmacy Promotion, the forum aimed to foster international collaboration and advance regulatory science in the field of biosimilars.
The forum brought together experts and scholars from industry, government, and academia across six countries—Germany, Japan, Sweden, Taiwan, Thailand, and the United States—to exchange insights on the development and regulatory issues of biosimilars worldwide. The discussion covered a wide range of topics, including perspectives from regulatory authorities, experience sharing from the biopharmaceutical industry, academic insights into regulatory science, and strategies to enhance the accessibility and utilization of biosimilars from both policy and clinical standpoints (please refer to the program agenda). The forum also underscored the importance of promoting regulatory science education, as well as facilitating interdisciplinary integration and interagency collaboration.
Moreover, the forum received strong support from Taiwan’s government agencies. The Taiwan Food and Drug Administration (TFDA), National Health Insurance Administration (NHIA), and the Center for Drug Evaluation (CDE) each appointed senior officials or experts to deliver presentations. Their active involvement reflected Taiwan’s dedication to advancing regulatory science and promoting cross-sector dialogue.
The success of the forum was made possible through the generous support of the National Taiwan University School of Pharmacy Endowment Fund, the National Science and Technology Council, and the National Taiwan University College of Medicine. 2025國際法規科學論壇
International Regulatory Science Forum 2025
Developing Biosimilars: Challenges and Perspectives
臺大藥學專業學院於2025年3月21日至22日舉辦「2025國際法規科學論壇」，由美國南加州大學、台灣醫藥品法規學會、台灣藥學會，以及財團法人中華景康藥學基金會共同協辦，旨在促進國際合作，推動生物相似藥領域法規科學的發展與交流。
本論壇集結來自德國、日本、瑞典、臺灣、泰國、與美國等六國的產官學界專家學者，針對全球生物相似藥的開發與法規議題交換見解。討論內容涵蓋主管機關的觀點、生技製藥產業的經驗分享、學術界對法規科學議題的探討，以及從政策與臨床角度出發，促進生物相似藥可近性與使用的策略 (請參見議程)。研討會中亦提及推動法規科學教育，以及促進跨領域整合與跨部門合作的重要性。
此外，本論壇亦獲得國內主管機關大力支持，包括衛生福利部食品藥物管理署、中央健康保險署及財團法人醫藥品查驗中心等，分別指派高階官員、專家進行專題演講，展現臺灣政府推動法規科學發展與跨領域對話的決心。
本次研討會活動承蒙臺大藥學發展永續基金計畫、國家科學及技術委員會、及臺大醫學院之支持與贊助，順利圓滿舉行。 Speech photos
活動剪影

 

 

 

Opening Remarks
Shan-Chwen Chang, MD, PhD

• Executive Vice President, National Taiwan University
• Distinguished Professor, Department of Internal Medicine, College of Medicine, National Taiwan University

Chiun Hsu, MD, PhD

• Associate Dean, College of Medicine, National Taiwan University

Chun-Jung (Clement) Lin, PhD

• Dean, School of Pharmacy, College of Medicine, National Taiwan University
• Professor, School of Pharmacy, College of Medicine, National Taiwan University

Eunjoo Pacifici, PharmD, PhD

• Chair & Associate Professor, Department of Regulatory and Quality Sciences, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, USA

Shianging (Shirley) Pan, MSc

• Senior Technical Specialist, Division of Medicinal Products, Taiwan Food and Drug Administration (TFDA)

Keynote Lecture
Biosimilars: Opportunities and Challenges to a Sustainable Healthcare System
Moderator:
Jaw-Jou Kang, PhD

• President, Taiwan Society of Regulatory Affairs for Medical Products (TsRAP)
• Professor Emeritus, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University (NYCU), Taiwan

Speaker:
Sreedhar Sagi, MD, PhD

• Head of Medical Affairs, Sandoz International Region, Sandoz

Session 1:
Regulatory Challenges for Biosimilars: Perspectives from Regulatory Authorities
Moderator:
Jaw-Jou Kang, PhD

• President, Taiwan Society of Regulatory Affairs for Medical Products (TsRAP)
• Professor Emeritus, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University (NYCU), Taiwan

Topics and Speakers:

1. Regulation of Biosimilar Products in Taiwan

Chi-Hsun Chen, MD

• Senior Clinical Section Chief, Division of New Drugs, Center for Drug Evaluation (CDE), Taiwan

1. Current Regulation on Biosimilar in Japan

Keisuke Tanaka, PhD

• Reviewer, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

1. Biosimilars Development and Approval – Current Status in The United States (December 2024)

Yow-Ming Wang, PhD

• Associate Director, Biosimilars and Therapeutic Biologics, Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), USA

Session 2:
Bio Industries' Points of View: Sharing Experiences and Challenges on Biosimilars
Moderator:
Frances Richmond, PhD

• Professor Emerita, Regulatory and Quality Sciences, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, USA

Topics and Speakers:

1. Overcoming Barriers in Biosimilar Development: Insights and Practical Recommendations

Lee-Cheng Liu, PhD

• Founder, Chairman, and CEO of EirGenix, Inc., Taiwan

1. Towards Streamlined Biosimilars Development – The Results of 20 Years of Success in the Clinic

Klaus Martin, PhD

• Independent Consultant
• CEO (part-time), Nodal Therapeutics, USA
• Member, Scientific Advisory Board, JJP Biologics, Poland

1. Biosimilar Development: Insights from a Biologic Developer

Mary Wilhelm, DRSc, RAC

• Independent Consultant
• Senior Director Regulatory Affairs, Ascendis Pharma, USA
• Guest Lecturer, University of Southern California, USA

1. Chemistry, Manufacturing, and Controls (CMC) Management for Biosimilar Production

Lequina Myles, DRSc, MBA, RAC, CSSBB, PfMP, PgMP, PMP

• Vice President, Quality Assurance and Regulatory Affairs, and Business Unit Manager, Phenomenex, USA
• Guest Lecturer, University of Southern California, USA
• Guest Lecturer, Cedars-Sinai, USA
• Adjunct Faculty, Mount Saint Mary's University, USA

Closing Remarks
Eunjoo Pacifici, PharmD, PhD

• Chair & Associate Professor, Department of Regulatory and Quality Sciences, Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, USA

Session 3:
Regulatory Science Issues for Biosimilars: Perspectives from Academia
Moderator:
Churn-Shiouh Gau, PhD

• President, The Pharmaceutical Society of Taiwan (PST)
• Director, Platform for Research and Inspiration in Regulatory Science, School of Pharmacy, College of Medicine, National Taiwan University
• Adjunct Professor, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan

Topics and Speakers:

1. Biosimilar Research in Academia: Analytical Science and Epidemiological Research

Atsushi Yonezawa, PhD

• Professor, Division of Integrative Clinical Pharmacology, Faculty of Pharmacy, Keio University, Japan

1. Navigating Biosimilar Regulation: Academic Insights

Leena Suntornsuk, PhD

• Professor, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol University, Thailand

1. Immunogenicity and Biosimilars: Labeling Evolution and Regulatory Implications for Drug Safety

Lin-Chau Chang, PhD

• Associate Professor, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan

Session 4:
Accessibility and Utilization:

1. Health Policy to Enhance Clinical Utilization<

1. Clinical Experience Sharing

Moderator:

1. Li-Ying (Grace) Huang, PhD

• Director, Division of Health Technology Assessment, Center for Drug Evaluation, Taiwan
• Board of Directors HTAi

1. Mei-Ling Hsiao, MSc

• Honorary President, Taiwan Society of Regulatory Affairs for Medical Products (TsRAP)
• Distinguished Specialist, National Yang Ming Chiao Tung University (NYCU), Taiwan
• Distinguished Specialist, National Cheng Kung University (NCKU), Taiwan

Topics and Speakers:

1. The Swedish Reimbursement System for Medicines, with a Focus on Biosimilar

Niklas Hedberg, MSc

• Chief Pharmacist, TLV, Sweden
• Chair, EUnetHTA Executive Board

Fredrika Ryden, RPh

• Senior Medical Investigator, The Dental and Pharmaceutical Benefits Agency (TLV), Sweden

1. Strategies for Reimbursement of Biosimilars Under the Health Insurance System in Taiwan

Yu-Wen Huang, PhD

• Director, Medical Review and Pharmaceutical Division, Insurance Administration, Ministry of Health and Welfare, Taiwan

1. Clinical Adoption and Integration of Biosimilars in Healthcare Systems

Shao-Chin Chiang, PharmD

• Director, Center for Advanced Pharmacy Education, Department of Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center, Taiwan
• Assistant Professor, Department of Pharmacy, National Yang Ming Chiao Tung University, Taiwan
• Director, Taiwan Society of Regulatory Affairs for Medical Products

1. Implementation Experiences of Biosimilar Policies in Taiwanese Hospital Settings

Yuk-Ying Chan, MS

• Chief of the Department of Pharmacy Administration at the Chang Gung Medical Foundation, Taiwan

Closing Remarks
Churn-Shiouh Gau, PhD

• President, The Pharmaceutical Society of Taiwan (PST)
• Director, Platform for Research and Inspiration in Regulatory Science, School of Pharmacy, College of Medicine, National Taiwan University
• Adjunct Professor, School of Pharmacy, College of Medicine, National Taiwan University, Taiwan

Forum Agenda
議程