1st Day Registration

Design and Analysis of Biosimilar Studies

The course is instructed by: Shein-Chung CHOW, PhD • Professor, Biostatistics and Bioinformatics, Duke University School of Medicine, USA • Special Government Employee and statistical consultant of the US FDA; • Editor-in-Chief of the: Journal of Biosimilars; the Journal of Biopharmaceutical Statistics and the Drug Designing, • More than 30 years of experience in pharmaceutical/clinical development • Author or co-author of over 280 methodology papers and 24 books including Biosimilars: Design and Analysis of Follow-on Biologics

The materials of the course are developed based on

• the book entitled “Biosimilars: Design and Analysis of Follow-on Biologics” by Chow SC published in 2013 by Chapman and Hall/CRCPress, Taylor & Francis, New York,
• and the 3rd edition of the book entitled “Design and Analysis of Bioavailability and Bioequivalence Studies” by Chow SC and Liu JP published in 2008 by Chapman and Hall/CRC Press, Taylor & Francis, New York.

Schedule of the course:

14:00 – 15:00   |   Lecture 1: Assessing Biosimilarity: Issues and Recent

Development
• Fundamental differences: Generics versus biosimilars
• Regulatory requirements: EU EMA, US FDA, and WHO
• Definition of biosimilarity: US BPCI Act
• Scientific factors for assessing biosimilarity: Criteria for biosimilarity | Non-inferiority vs. equivalence | Multiple reference products
• Development of biosimilarity index: Unified and robust approach
• Concluding remarks

15:00 – 15:30   |   Coffee break: refreshments & networking

15:30 – 16:30   |   Lecture 2: Assessing Interchangeability

Issues, Designs, and Statistical methods
• Concept of interchangeability: Switching | Alternating
• Current issues: Produce same clinical results in any given patient
• Criteria for interchangeability: Adjust for variability of reference product
• Study designs: Switching designs
• Statistical methods
• Concluding remarks

16:30 – 17:00   |   Coffee break: refreshments & networking

17:00 – 18:00   |   Lecture 3: Analytical Similarity Assessment in Biosimilar Studies

Background
• BPCI’s definition of biosimilarity
• FDA’s guidances on biosimilars
• Recent regulatory submission

Analytical similarity assessment
• Classification of critical quality attributes (CQAs)
• Tiered approach
– Equivalence test for Tier 1 CQAs
– Quality range approach for Tier 2 CQAs
– Raw data and graphical comparison for Tier 3 CQAs

US FDA’s current thinking on Tiered approach

2nd Day Registration (for those attending only day 2)

Keynote lecture: Interchangeability of biological drug products

László ENDRÉNYI, Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists

László TÓTHFALUSI, Associate Professor, Faculty of Pharmacology, Semmelweis Medical University, Budapest

Clinical trials for authorised biosimilars in the European Union: A systematic review

Johanna MIELKE, Biostatistician, Novartis Pharma AG

Co-authors:

Bernd JILMA, Vice Chair, Department Clinical Pharmacology, Medical University of Vienna

Franz KÖNIG, Associate Professor, Medical Unversity of Vienna, Section for Medical Statistics

Byron JONES, Consultant, Statistical Methodology and Consulting Group at Novartis Pharma AG in Basel

Biosimilar development – a statistical assessor’s perspective

Stephan LEHR, Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS

Coffee Break

The regulator’s view on the totality of evidence for biosimilars

Andrea LASLOP, Unit Head, Austrian Medicines and Medical Devices Agency

The intention to treat principle and imputation of missing data in clinical studies for biosimilars

Júlia SINGER, Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics

Demonstrating similarity of clinical safety

Vid STANULOVIC, Consultant, Clinical Development and Pharmacovigilance

Evaluation of different methods to establish biosimilarity on the quality attributes level

Martin WOLFSEGGER, Director Pharmacometrics & Pre-Clinical Biostatistics, Shire

Lunch Break

Round table discussion:

Moderator:

Ildikó ARADI , Head of Clinical Development of Biologics, Gedeon Richter Plc., Vice-Chair, European Generic medicines Association – European Biosimilars Group

Panel members:

Péter ARÁNYI, Secretary, Medical Research Council, Ethics Committee for Clinical Pharmacology

Andrea LASLOP, Unit Head, Austrian Medicines and Medical Devices Agency

Stephan LEHR, Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS

Franz KÖNIG, Associate Professor, Medical Unversity of Vienna, Section for Medical Statistics

Johanna MIELKE, Biostatistician, Novartis Pharma AG

Júlia SINGER, Chief Scientific Officer, Accelsiors CRO Ltd.; President, Hungarian Society for Clinical Biostatistics

Vid STANULOVIC, Consultant, Clinical Development and Pharmacovigilance

Martin WOLFSEGGER, Director Pharmacometrics & Pre-Clinical Biostatistics, Shire

Heike WÖHLING, Head of Biostatistics, Sandoz Biopharmaceuticals