Chair: Shein-Chung Chow (Duke)
Thomas Gwise (Former FDA/CDER director)
Shein-Chung Chow (Duke)

Course Description:

Biological products are therapeutic agents produced using a living system or organism. In practice, access to these life-saving biological products is limited due to their expensive cost. In the next few years, many patents of the early biological products will expire. This provides other biopharmaceutical/biotech companies the opportunity to manufacture biosimilar products. For the conventional pharmaceuticals of small molecules, regulations and statistical methods for the assessment of bioequivalence for generic approval are well established. However, unlike the conventional drug products, the complexity and heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and the possibility of severe immunogenicity reactions make evaluation of equivalence (similarity) between an innovator and its biosimilar products a great challenge for both the scientific community and regulatory agencies.

This half-day workshop on biosimilar reviews past experiences for the assessment of biosimilarity for biosimilar products. An overview of current regulatory requirements for assessing biosimilarity of biosimilar products for obtaining the totality-of-the-evidence in support of regulatory submission are reviewed. Recent issues and development in assessing biosimilarity (including analytical similarity, PK/PD similarity, and clinical similarity) and interchangeability will also be discussed.

Thomas Gwise
Former FDA/CDER Director

Thomas GwiseDr. Thomas Gwise is a statistician with more than 17 years experience in drug and medical device review with the US Food and Drug Administration. Most recently, Dr. Gwise was the director of the Division of Biometrics IX in FDA’s Center for Drug Evaluation and Research (CDER) where he oversaw statistical review of all applications and INDs for hematological indications including cancers. Prior to his role as Director, Dr. Gwise was Deputy Director of CDER’s Division of Biometrics V which at that time reviewed applications for cancer and imaging drug indications.

Before transferring to CDER in 2011, he was a statistical reviewer and team leader in FDA’s Center for Devices and Radiological Health (CDRH) where he reviewed marketing applications for both therapeutic and diagnostic devices. During his time with CDER, Dr. Gwise was an integral member of FDA’s Biosimilar Review Committee which advises FDA therapeutic area divisions on biosimilar evaluation and application review. He led the statistical review of multiple biosimilar applications, participated in drafting and editing FDA guidance for biosimilars and interchangeable products, authored a book chapter on comparative clinical studies for biosimilar evaluation and co-authored articles on biosimilar margin selection.

Shein-Chung Chow, Ph.D.
Professor, Department of Biostatistics and Bioinformatics
Duke University School of Medicine
Durham, North Carolina, USA

Shein-Chung Chow, Ph.D. is currently a Professor at the Department of Biostatistics and Bioinformatics at Duke University. Dr. Chow was also a special government employee (SGE) appointed by the US FDA as an Oncologic Drug Advisory Committee (ODAC) voting member and Statistical Advisor to the FDA (2015-2017, 2019-2022). Dr. Chow was the Editor-in-Chief of the Journal of Biopharmaceutical Statistics (1992-2020) and is the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group.

Dr. Chow was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. Dr. Chow is the author or co-author of over 330 methodology papers and 33 books including Design and Analysis of Bioavailability and Bioequivalence Studies, Biosimilars: Design and Analysis of Follow-on Biologics, Biosimilar Product Development, Analytical Similarity Assessment in Biosimilar Drug Development, Advanced Statistics in Biosimilar Product Development, and most recently Advanced Statistics in Regulatory Critical Clinical Initiatives.