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Download All Presentations from the
Previous Biosimilars Forum

13 presentation materials from the programme of the professionally very fruitful 3rd Annual Biosimilars Forum are available to download as a courtesy of the event series. Don’t miss out, this exclusive offer is available only for a couple of weeks!

Sign-up now and get free access to the materials of the professional lectures in bio- and nanosimilar development!

Learn From Leading Drug Development Experts!

Inside you will find 13 presentation materials in biosimilar development delivered during the 3rd Biosimilars Forum by leading subject matter experts from the fields of regulatory, academic and clinical research (25-27 OCT, 2018).

These lectures provide essential information for research management, leadership and support teams working in and for bio- and nanosimilar drug development:

  • A detailed overview of recent development issues of follow-on biologics
  • and guidance for their handling
  • with a strong focus on the statistical and regulatory aspects of bio- and nanosimilar research

100% free. Sign up in 30 seconds and we will email you an access to the essential lectures in biosimilar development within 1 business day.

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List of Presentations

 1st PK Course (4-part lecture)

Uni- and multivariate Bioequivalence of PK parameters

Thomas JAKI
Professor of Statistics, Lancaster University, UK
Deputy Director Research Design and Conduct Service and Research Fellow, Cardiff University, UK

 2nd PK Course (3-part lecture)

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

Professor of Biostatistics at Leibniz Universität Hannover, Faculty of Natural Sciences, Germany

 Scientific Keynote Presentation

Bioequivalence of highly variable drug products – an update

Professor Emeritus of Pharmacology and Biostatistics, University of Toronto, Canada;
Co-author: László TÓTHFALUSI, Associate Professor, Semmelweis University, Hungary

 Case Study

An update on development strategies of recently approved biosimilars in Europe

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

 Regulatory Keynote Presentation

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

Unit Head, Austrian Medicines and Medical Devices Agency, Austria


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

Unit Head at National Institute of Pharmacy and Nutrition, Hungary

 Case Study

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

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

 Case Study

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

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

 Case Study

How the increase of assay sensitivity influences the immunogenicity

Director Biostatistics for Biostatistics Biosimilars, Analytics group,
Sandoz Biopharmaceuticals, Germany

 Case Study

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

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


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

 2-part 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

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