Photo gallery – 2nd Annual Biosimilars Forum (5-6 OCT, 2017)

Account of experiences about the 2nd Annual Biosimilars Forum

World’s prominent biosimilar development experts have returned to Budapest to the 2nd Annual Biosimilars Forum on 5 – 6 October, 2017.

Accelsiors CRO has partnered with the Viennese Section of the International Biometric Society and the Hungarian Society for Clinical Biostatistics once again to deliver this unique professional forum for research management, leadership and support teams working in and for biosimilar drug development.

The professionally very fruitful 2nd Biosimilars Forum was hosted in Budapest, 5 – 6 October, 2017 by Accelsiors CRO with participation of internationally renowned experts of biosimilar drug development such as Prof. Dr. László Endrényi (Professor Emeritus of University of Toronto), Andrea Laslop (Head of Scientific Office, Austrian Medicines and Medical Devices Agency), Helmut Schütz (Owner at BEBAC – Consultancy Services), and clinical researchers, biostatisticians, regulatory professionals and sponsors from around the world.

This year’s two-day forum covered important issues and specific areas of debate facing clinical development teams specialized on biosimilars. The program of the event was very comprehensive and integrated multiple perspectives on current biosimilar research.

Focused on statistical and regulatory perspectives of biosimilar development

The 2nd Annual Biosimilars Forum welcomed László Endrényi Professor Emeritus from the University of Toronto who presented a lecture about Scientific factors in biosimilar product development. A very substantial course was delivered by Helmut Schütz, owner at BEBAC – Consultancy Services, who gave a detailed overview about open issues in the assessment of bioequivalence and biosimilarity.

The EMA regulatory expert Andrea Laslop showcased her keynote presentation about the 12 years of biosimilars in Europe and provided an essential understanding of the European regulatory framework. The regulatory part of the forum was further strengthened by Ina-Christine Rondak’s lecture (Seconded National Expert from Technische Universität München to EMA), she presented a useful overview of regulatory perspective on comparison of quality attributes in drug development.

As a very interesting novelty in this year’s program Prof. Janos Szebeni, Director of the Nanomedicine Research and Education Center delivered a keynote presentation about the immune side effects and unsolved issues in bio- and nanosimilar development.

The program of the event gave deep insight into the statistical perspective of biosimilar research. The prominent lecturers such as László Tóthfalusi (Associate Professor of Semmelweis Medical University), Bernd Jilma (Vice Chair, Department Clinical Pharmacology, Medical University of Vienna) and Johanna Mielke (Biostatistician at Novartis Pharma AG) provided an overview about scientific principles and methodologies used in the design and analysis of biosimilar studies as well as their recent industry experiences.

The members of the round table section from industry, regulatory and academic site had a really fruitful and constructive discussion both on actual challenges and open issues of biosimilar development. The participants of this open discussion such as Stephan Lehr (Biostatistician, Austrian Medicines and Medical Devices Agency and President of Viennese Section of IBS), Heike Wöhling (Head of Biostatistics, Sandoz Biopharmaceuticals), Ildikó ARADI (Head of Clinical Development of Biologics, Gedeon Richter Plc., Vice-Chair, European Generic medicines Association – European Biosimilars Group), Franz KÖNIG (Associate Professor at Medical Unversity of Vienna, Section for Medical Statistics), Vid STANULOVIC (Consultant, Clinical Development and Pharmacovigilance) had a highly constructive conversation about regulatory and industry perspectives of biosimilars, recent developments, as well as about essential statistical methods and high-level research.

The organizers are delighted that they could establish an opportunity with this event series for a constructive and open dialogue between medical statisticians, regulatory professionals, clinical researchers and sponsors with whom they collaborate and many interested people visited the event to learn and network. Visitors could take part in the experience with some of the world’s most prominent experts of this innovative field who gave a detailed overview in biosimilar product development and gave a guidance how to adjust clinical research practice to effective legislation or vice versa, raised ideas on how legislation could be developed further to meet the challenges this quickly developing field pose.

The organizers of the 2nd Annual Biosimilars Forum are proud that they once more had the chance to support biosimilar development professionals and they have assisted in sharing of recent scientific and practical knowledge aimed at increasing effectiveness of drug research.


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

Title of lecture:

Scientific factors in biosimilar product development

Owner at
BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies

Title of course:

Open issues in the assessment of bioequivalence and biosimilarity

Unit Head,

Austrian Medicines and Medical Devices Agency

Title of keynote presentation:

12 years of biosimilars in Europe:
What is the exposure and response in our learning curve?

Vice Chair,
Department Clinical Pharmacology, Medical University of Vienna

Title of lecture:

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

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

Title of lecture:

Statistical considerations in the biosimilarity assessment of quality attributes

Johanna MIELKE

Novartis Pharma AG

Title of lecture:

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

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

Title of lecture:

Regulatory perspective on comparison of quality attributes in drug development

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

Title of lecture:

Immune side effects of biologicals and nanomedicines: unsolved issues in bio- and nanosimilar development

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

Title of lecture:

Algorithms for evaluating reference scaled average bioequivalence: Power, bias and consumer risk

(co-author and lecturer: László Endrényi)