This two-day series of events consists of a COURSE DAY (October 5th) and a professional SYMPOSIUM DAY (invited presentations and round table session, scheduled for October 6th) regarding hot topics related to the development of biosimilars with strong FOCUS ON Statistical and Regulatory Perspectives.

Focus on the most actual challenges of biosimilar development

This unique forum will cover important issues and specific areas of controversy facing clinical development teams. It is particularly useful for those who are interested in constructive and open dialogue between medical statisticians, regulatory professionals, clinical researchers and sponsors with whom they collaborate.


The program of the event will be supported and complemented by international subject experts. The final agenda and the list of lectures and speakers of the 2nd Biosimilars Forum is under preparation.

Keynote presentations:

12 years of biosimilars in Europe: 

What is the exposure and response
in our learning curve?

Unit Head,
Austrian Medicines and Medical Devices Agency


Immune side effects of biologicals and nanomedicines:

unsolved issues in
bio- and nanosimilar development.

Director of the Nanomedicine Research and Education Center at Semmelweis Medical University, Budapest,
Professor at University of Miskolc, Department of Nanobiotechnology and the Regenerative Medicine, Institute of Theoretical Medicine

1st day: COURSES with special lecturers

5th OCTOBER, 2017

Title of lecture:

Scientific factors in biosimilar product development

The lecture is presented by:


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

Course title:

Open issues in the assessment of bioequivalence and biosimilarity

The course is lectured by:

Helmut SCHÜTZ,

Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies

2nd day: Professional SYMPOSIUM and ROUND TABLE

6th OCTOBER, 2017

Planned programme of the day width a strong

FOCUS on Statistical and Regulatory Perspectives in Bio- and Nanosimilar Development

Planned topics for presentations and discussions with participation of scientific experts and prominent professionals from the field of clinical research:

EMA “Statistics for quality comparison” reflection paper is out for public consultation (problem statement, and feedback from industry received)

– Recent developments in assessing biosimilarity
– Clinical study designs
– Update on the last year review of the development program of registered Biosimilars in the EU (based on the EPARs)

Some professional lectures from the programme of the day:

  • Investigating PK/PD in the steep ascending part of the dose response curve

presented by Bernd JILMA
(Vice Chair, Department Clinical Pharmacology, Medical University of Vienna)

  • Statistical considerations in the biosimilarity assessment of quality attributes

presented by Stephan LEHR
(Biostatistician, Austrian Medicines and Medical Devices Agency, President, Viennese Section of IBS)

Regulatory perspective on comparison of quality attributes in drug development

presented by Ina-Christine RONDAK
(Biostatistician, Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA)

  • Algorithms for evaluating reference scaled average bioequivalence: Power, bias and consumer risk
presented by László TÓTHFALUSI
(Associate Professor, Faculty of Pharmacology, Semmelweis Medical University of Budapest)
and László ENDRÉNYI
(Professor Emeritus of Pharmacology and Biostatistics, University of Toronto; Former President of Canadian Society for Pharmaceutical Scientists)

  • Clinical trials for biosimilars in Europe: an updated systematic comparison of the clinical development programs

presented by Johanna MIELKE
(Biostatistician, Novartis Pharma AG)