This 3-day series of events consists of a COURSE DAY with two professional lecture sessions (October 25th), a SYMPOSIUM DAY (invited presentations, posters and round table session, scheduled for October 26th) and a SEMINAR DAY (lectured by special experts from the field of nanotechnology-formulated drug development – October 27th) comprising issues in Bio- and Nanosimilar development with strong FOCUS ON Statistical and Regulatory Perspectives.

The event provides a detailed overview of current development issues of follow-on biologics and guidance for their handling. The Annual Biosimilars Forum event series examines the actual challenges of biosimilar drug development with for research management, leadership and support teams working in and for biosimilars.


  Quick-links:     |     COURSE DAY    |     SYMPOSIUM DAY        SEMINAR DAY   

The World’s prominent biosimilar development experts from the fields of regulatory, academic and clinical research will return to Budapest in 2018 to the 3rd Annual Biosimilars Forum on October.

25th OCTOBER, 2018 | 1st day: COURSES with special lecturers
with 2 professional course sessions on statistical and pharmacokinetical aspects of biosimilarity assessment, will be delivered by prominent biosimilar research expert scientists:


Uni- and multivariate Bioequivalence of
PK parameters

Lecturers of the Morning Course Session:

Thomas JAKI
Professor of Statistics, Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, UK

in cooperation with

Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK


Testing for the equivalence of the pharmacokinetic behaviour of compounds is an indispensable task in biosimilar and generic development. In many cases this is done on the basis of pharmacokinetic (PK) parameters that summarize how the compound is absorbed, distributed, metabolised and excreted.

In this course we will briefly discuss how different PK parameters can be estimated using a non-compartmental approach and then show how bioequivalence can be assessed on the basis of a single as well as multiple PK parameters.

The R packages PK and jocre will be presented.


Statistical aspects of equivalence testing for biosimilar studies: multiple, differently-scaled endpoints

Lecturer: Ludwig A. HOTHORN
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany

  • Preclinical biosimilar assays consider both bioequivalence (PK) and equivalence (surrogate therapeutic endpoints)
  • Multiple endpoints are common, and they are not necessarily equally distributed.
  • Equivalence thresholds are, if ever, defined as ratios. Therefore, ratio-to-comparator tests and confidence intervals are needed.
  • Commonly log-normal distribution is assumed. Alternatives for normal distribution (including variance heterogeneity) or any distribution (rank statistics) will be discussed. Claiming equivalence for multiple correlated endpoints is challenging.
  • The pros and cons of multivariate tests and intersection-union tests are discussed.
  • Sometimes bioassays with multiple biosimilars with respect to a single comparator are considered.
  • The pros and cons of multiplicity adjustment will be discussed.
  • The three topics will be explained by means of real data examples using CRAN packages.

Tickets are available now with flexible terms. Please send us your registration as soon as possible because places are limited in number! WBS and ISCB members can attend the 2nd day symposium for free.
Join us for discovery, networking and meet leading biosimilar development experts at our Forum!

26th OCTOBER, 2018 | 2nd day: Professional SYMPOSIUM and ROUND TABLE


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 3rd Annual Biosimilars Forum.

Email us your Abstract, participate at our 3rd event with your professional work!

Planned programme of the day with a strong

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

As in previous years, visitors can take part in the event with world-prominent subject experts from the biosimilars and nanosimilars development areas who will be providing an overview of current regulatory requirements for assessing biosimilarity of biosimilar products and giving detailed guidance to handle differences between regulatory guideline recommendations and clinical research practice.
The detailed agenda and list of speakers of the Symposium day are under preparation, the program of the event will continue to expand until October with internationally renowned speakers from the biosimilars and nanosimilars area.
Some professional lectures from the programme of the Symposium day:

Scientific Keynote Presentation:

Bioequivalence of highly variable drug products – an update

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

Co-author: László TÓTHFALUSI,
Associate Professor,
Faculty of Pharmacology, Semmelweis Medical University, Budapest, Hungary

Regulatory Keynote Presentation:

The biosimilar concept revisited – is there a need for change?

European Regulatory Expert; Unit Head, Austrian Medicines and Medical Devices Agency, Austria

An update on development strategies of recently approved biosimilars in Europe

Johanna MIELKE
Early Stage Researcher; Biostatistician, Novartis Pharma AG

Challenges with safety assessments in biosimilar studies

Emmanuelle VINCENT
Head of Biostatistics and Data Management, Fresenius-Kabi, Switzerland

Animal models of immunogenicity and immune toxico-equivalence testing of nano-biopharmaceuticals

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

Biosimilars in paediatrics: extrapolation of totality of evidence, indications, and other possible challenges

Hungarian member of EMA Committee for Human Medicinal Products (CHMP), and EMA Paediatric Committee (PDCO); Unit Head at National Institute of Pharmacy and Nutrition, Hungary

How the increase of assay sensitivity influences the immunogenicity assessment

Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis, Germany

Incorporating historical information in biosimilar trials: Challenges and a hybrid Bayesian‐frequentist approach

Johanna MIELKE
Early Stage Researcher; Biostatistician, Novartis Pharma AG

This page is frequently being updated, the detailed program of the 2nd day will be available soon, so please come back to learn more.
Tickets are available now with flexible terms. Please send us your registration as soon as possible because places are limited in number! WBS and ISCB members can attend the 2nd day symposium for free.
Join us for discovery, networking and meet leading biosimilar development experts at our Forum!

27th OCTOBER, 2018 | 3rd day: Professional SEMINAR

Planned programme of the day with a strong focus on

Nanotechnology in drug development

The programme of the 3rd day is dedicated to professional Seminar sessions with a strong focus on current perspectives of Biosimilar and Nanosimilar drug development, will be delivered by special international experts from the field of nanotechnology-formulated drug development.
Some professional lectures from the programme of the SEMINAR day:

Professional Seminar:

The Era of Biosimilars and Nanosimilars: Current Perspectives

President of Bawa Biotech LLC; Adjunct Professor at Rensselaer Polytechnic Institute, USA; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; USA

The immunological characterization of nanotechnology-formulated drugs

Senior Principal Scientist and Head of the Immunology Section at the Nanotechnology Characterization Laboratory, USA

Targeted Nanomedicine: State of Art and Future Developments

Professor of Targeted Nanomedicine at the Department of Pharmaceuticst of the University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands


Ildikó ARADI 
Vice-Chair, Medicines for Europe, Biosimilar Medicines Group; Head of Clinical Development of Biologics, Gedeon Richter Plc.

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; President, Viennese Section of IBS

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


Director Biostatistics for Biostatistics Biosimilars, Analytics group, Novartis


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.