The presentation materials of the professionally very fruitful 2nd Annual Biosimilars Forum are now available to download as courtesy of the organizers of the event series. Here are the links below to reach your copies:

5 OCT, 2017 | 1st DAY COURSES

Scientific factors in biosimilar product development
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists

Presentation material
(.PDF, 1319 KB)

Open issues in the assessment of bioequivalence and biosimilarity
The course is lectured by:
Helmut Schütz,
Owner at BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies

Benefit from our expertise in biosimilars

Accelsiors’ biosimilar team is ready to accelerate your development program! Combining our proficiency in different therapeutic areas, with well-tailored service capabilities and access to diverse patient populations, Accelsiors will support every aspect of clinical and nonclinical development of your biosimilar or biobetter compound – from the concept through pre-clinical development to successful conduct of Phase III registration trial.

Some of Accelsiors - The scientific driven CRO‘ values provided for your success:

2 decades of experiences in biosimilar clinical trials

biosimilar knowledge base

Dedicated team of biosimilar

Time- and cost efficient solutions to accelerate your program

Global resources
with a flexible local support

Complete range
of expertise tailored for your specific needs


Feel free to ask Accelsiors - The scientific driven CRO‘ Biosimilar Reserach experts!

Work together with the pioneers in biosimilars

Accelsiors is a scientific-driven, global, full-service CRO with extensive professional background in biosimilars development. Our professionals were among the first pioneers in the biosimilars field since we have been supporting biosimilar development programs form 1996 with the first biosimilar, somatotropin.
Let us to accelerate your biosimilar program by sharing with you our expertise and well-tailored service capabilities!

6 OCT, 2017 | 2nd DAY SYMPOSIUM

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

Johanna MIELKE,
Novartis Pharma AG

Presentation material
(.PDF, 637 KB)

Algorithms for evaluating reference scaled average bioequivalence: power, bias and consumer risk
Associate Professor,
Faculty of Pharmacology, Semmelweis Medical University, Budapest
Co-author: László ENDRÉNYI,
Professor Emeritus of Pharmacology and Biostatistics, University of Toronto;
Former President of Canadian Society for Pharmaceutical Scientists

Presentation material
(.PDF, 1748 KB)

1st Keynote lecture: 12 years of biosimilars in Europe: what’s the exposure and response in our learning curve?
Andrea LASLOP,
Unit Head,
Austrian Medicines and Medical Devices Agency

Presentation material
(.PDF, 1019 KB)

Regulatory perspective on comparison of quality attributes in drug development
Ina-Christine RONDAK,
Seconded National Expert from Klinikum rechts der Isar of Technische Universität München to EMA

Presentation material
(.PDF, 783 KB)

2nd Keynote lecture: Immune side effects of biologicals and nanomedicines: unsolved issues in bio- and nanosimilar 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

Presentation material
(.PDF, 6 439KB)

Round table discussion:
Regulatory perspective: Stephan LEHR,
Biostatistician, Austrian Medicines and Medical Devices Agency,
President, Viennese Section of IBS
Industry perspective: Heike WÖHLING,
Head of Biostatistics,
Sandoz Biopharmaceuticals

Leaflet of the 2nd Annual Biosimilrs Forum with Agenda

Leaflet of the Forum
(.PDF, 1.15 MB)

Copyrights notice

© Copyrights: All of these presentation materilas and the content of these are owned by the authors of the lectures and are protected by copyright laws and international treaty provisions. Reproduction of any material on these lectures is only authorized for exclusive information for strictly personal and private use. Any reproduction and/or representation of all or part of the lectures, or any of the elements that compose it, on any media whatsoever, for any other purpose, including commercial, is expressly prohibited, unless the prior written authorization from the authors.