Based on the success of our last years’ events, we started to prepare our next, 4th Annual Biosimilars Forum, will be held on 17-18 October, 2019 in Budapest. The event will provide a detailed overview of current development issues of follow-on biologics and guidance for their handling.

The specialty of the series is that it brings the regulators, industry leaders, clinical researchers as well as medical scientists together from around the world and provides an opportunity for a constructive dialogue between them about the burning issues and challenges of biosimilars.

CALL FOR ABSTRACT SUBMISSIONS

This year the Scientific Programme Committee plans to organize a Contributed Papers section and a Poster section within the Forum.

The organizers are pleased to invite authors to submit abstracts for poster and oral symposium presentations to be delivered at the 4th Annual Biosimilars Forum.

Email us your Abstract, participate at our event this year with your professional work!

PROGRAMME OF THE 4th ANNUAL BIOSIMILARS FORUM (17-18 OCT, 2019)

This 2-day series of events consists of a professional short COURSE in advanced biostatistics (on October 17th) and a SYMPOSIUM DAY with invited presentations, posters and round table session (scheduled for October 18th) comprising burning issues in Biosimilar development with a dedicated focus on the statistical and regulatory aspects of follow-on biologics.

During these two interactive days the forum ensures maximum knowledge transfer among professionals, regulators and leading subject matter experts in biosimilar development to exchange and elaborate on the best practices and debate the evolving landscape, pitfalls and current prespectives of biosimilars.

COURSE DAY

17 OCT, 2019

Professional short course in advanced biostatistics:

Robust methods for assessment of average and scaled average bioequivalence

Presenters:

Robert SCHALL
Professor, Department of Mathematical Statistics and Actuarial Science, University of the Free State, South Africa

in cooperation with

Divan BURGER
Senior Lecturer, Department of Statistics, University of Pretoria, South Africa

SYMPOSIUM DAY

18 OCT, 2019

with invited professional presentations, posters and round table session, will be focusing on statistical and regulatory perspectives in biosimilar development.

Regulatory Keynote Speaker: Andrea LASLOP
European Regulatory Expert, Unit Head, Austrian Medicines and Medical Devices Agency, Austria
Scientific Keynote Speaker: László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Canada

The program for the second day will continue to expand until October with internationally renowned experts from the fields of regulatory, academic and clinical research who will be providing a detailed overview of current development issues of follow-on biologics and guidance for their handling. The agenda will be available soon here, until then we recommend you read more about our previous events!

Early Bird tickets with 30% discount are available now. WBS & ISCB members can attend the 2nd day symposium for free. Send us your registration as soon as possible because places are limited in number!

Scientific Programme Committee

Ildikó ARADI 
Vice-Chair, Medicines for Europe, Biosimilar Medicines Group

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

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

Stephan LEHR 
Statistician, Austrian Medicines and Medical Devices Agency

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

Heike WÖHLING
Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis

We had 3 very successful and professionally fruitful events in the previous years in a row, please read more about our former forums!

The summary page about our previous events is available in:

LEARN MORE ABOUT THE PREVIOUS EVENTS!

At the Annual Biosimilars Forum event series, clinicians, statisticians and regulatory representatives gathered together from around the world to share with each other their perspectives on this key topic of research.
Click on the button below and take a look at the professional lectures of our events, short video interviews with the key speakers, photo galleries and more.

CONFERENCE REPORT – 3rd BIOSIMILARS FORUM (2018 OCT.)

Summary article with all the presentation materials of the professionally very fruitful 3rd Annual Biosimilars Forum are available now for free as a courtesy of the event series.

SOME SPEAKERS FROM OUR PREVIOUS FORUMS

Shein-Chung CHOW
Professor, Department of Biostatistics and Bioinformatics, Duke University School of Medicine, USA

László ENDRÉNYI
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Canada

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

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

Helmut SCHÜTZ
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies, Austria

János SZEBENI
Director of the Nanomedicine Research and Education Center, Semmelweis Medical University, Budapest, Hungary

TESTIMONIALS

  • Bring the Regulators and Producer Companies together into one room is an excellent idea and a beautiful concept.

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

  • I think it’s very nicely covers the whole biosimilar development process… Broader roles could benefit from this conference!

    –Ildikó ARADI | Vice-Chair, Medicines for Europe, Biosimilar Medicines Group

  • These conferences are extremely useful, they provide discussions in many problems and issues. I hope very much that the series will continue …

    –László ENDRÉNYI | Professor Emeritus of Pharmacology and Biostatistics, University of Toronto

  • The Organizers really done a very good job trying to put together such a conference where we can exchange an idea regarding the regulatory approval process and also on some actual issues in the biosimilar drug development process.

    –Shein-Chung CHOW | Professor, Duke University School of Medicine

  • These meetings, where experts are coming together from the same or different countries bring something new: collaborations, new knowledge, so this is very precious.

    –János SZEBENI | Director of the Nanomedicine Research and Education Center at Semmelweis University