AGENDA OF THE 1ST ANNUAL BIOSIMILARS FORUM (2016)

This two-day series of events consisted of a COURSE DAY (October 6th, 2016) and a professional SYMPOSIUM DAY (invited presentations and round table session, scheduled for October 7th, 2016) regarding hot topics related to the development of biosimilars with strong Statistical Methodologies in Biosimilar Studies.
6th OCTOBER, 2016

1st day: COURSE with special lecturer

13:00 – 14:00 

1st Day Registration

14:00 – 18:00

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

7th OCTOBER, 2016

2nd day: SYMPOSIUM and ROUND TABLE SECTION

9:30 – 10:00 

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

10:00 – 10:30

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

10:30 – 10:50

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

10:50 – 11:10

Biosimilar development – a statistical assessor’s perspective

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

11:10 – 11:30

Coffee Break

11:30 – 11:50

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

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

11:50 – 12:10

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

12:10 – 12:35

Demonstrating similarity of clinical safety

Vid STANULOVIC,
Consultant,
Clinical Development and Pharmacovigilance

12:30 – 12:50

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

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

12:50 – 13:45

Lunch Break

13:45 – 15:45

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