Leading bio- and nanosimilar drug development experts returned to Budapest from the fields of regulatory, academic and clinical research to the 3rd Biosimilars Forum to focus together on the statistical and regulatory aspects of biosimilar drug development. The programme of this 3-day event provided a detailed overview of current development issues of follow-on biologics and guidance for their handling.


Please watch these short video interviews with the key speakers of the 3rd Biosimilars Forum, summarizing their thoughts about the professional topic of the conference and sharing their experiences on this three-day event. We asked them about that

  • Which are the most important challenges to overcome in the development of biosimilars in their field of research?
  • Which are the area in which more guidance would needed?
  • And we also asked them about the added values of this professional conference series in biosimilar development.


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.



25 OCT, 2018 | 1st DAY: PK COURSES

Morning Course Session:
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
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK

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

The course is lectured by:
Ludwig A. HOTHORN,
Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany

26 OCT, 2018 | 2nd DAY SYMPOSIUM AND ROUND TABLE: Clinical Research and Regulatory

An update on development strategies of recently approved biosimilars in Europe

Johanna MIELKE,
Early Stage Research Fellow,
IDEAS Innovative Training Network, Germany

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

Challenging issues in extrapolation of totality of evidence to pediatric indications in case of biosimilars

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

Regulatory Keynote Presentation:
The biosimilar concept revisited – is there a need for change?

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

Opportunities and limitations of a blinded sample size reassessment in biosimilars development

Emmanuelle VINCENT,
Head of Biostatistics and Data Management,

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

Johanna MIELKE,
Early Stage Research Fellow,
IDEAS Innovative Training Network, Germany

How the increase of assay sensitivity influences the immunogenicity

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

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 the Regenerative Medicine, Institute of Theoretical Medicine

27 OCT, 2018 | 3rd DAY SEMINAR in Nanomedicines

The Era of Biosimilars and Nanosimilars: Current Perspectives

President of Bawa Biotech LLC; Scientific Advisor at Teva Pharmaceutical Industries, Israel; Founding Director of American Society for Nanomedicine; Editor-in-Chief of the Handbook of Clinical Nanomedicine: Nanoparticles, Imaging, Therapy, and Clinical Applications, (CRC Press, 2016); 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 University of Utrecht; Professor of Targeted Therapeutics at the MIRA Institute of the University of Twente; The Netherlands

We had a successful and professionally fruitful event together in this year.
If you need more professional help or support regarding biosimilar development, please, do not hesitate to contact Accelsiors’ Biosimilar Research Team!