Improve your knowledge and confidence in biosimilars with this curriculum of eLearning modules. Expert authors, Professor Huub Schellekens, Dr Mathias Flume and Dr Paul Cornes, will take you through the full story of biosimilars from the analytical and clinical development process to how to effectively communicate with your patients about them.
Each module will take up to 20 minutes to complete. An application for accreditation of this curriculum has been made to EACCME®. To claim your credits, please select the appropriate box in the evaluation form at the end of the activity. Credits are only commensurate with completion of all of the designated modules.
This expert authored eLearning module focuses on explaining the concept of immunogenicity and how it affects the safety of biosimilars. This module also provides some considerations on how to interpret immunogenicity data in clinical practice.
This expert authored eLearning module looks at the clinical development process of biosimilars, particularly the importance of clinical trials to demonstrate biosimilarity.
More modules coming soon...
Through a combination of evidence and expert commentary, we will also look at the following key topics:
- Why do we need biosimilars? – Professor Huub Schellekens
- The analytics – Dr Mathias Flume
- Improving confidence by explaining key terminology – Professor Huub Schellekens
- The patient conversation – Dr Paul Cornes
All medical oncologists, specialist nurses, and allied healthcare professionals working with patients for whom biosimilars may represent a treatment option.
Faculty and disclosures
Dr Paul Cornes (BM BCH MA MRCP FRCR) has trained in Medicine at Oxford University and in Oncology at the Royal Marsden Hospital, London, UK before becoming a Consultant Oncologist in Bristol, UK.
He is part of the steering group for the European School of Oncology Working Party on the Access to Innovation in Cancer Treatment. He was on the faculty for the annual ECCO European CanCer Organisation meeting and ESMO-Barcelona – speaking on Innovation and Value-based medicine.
Paul was part of the team that developed and presented evidence to the Oncologic Drugs Advisory Committee of the FDA for the first successfully approved US biosimilar. He is a faculty member for the Continuing Medical Education programme of the European Association of Hospital Pharmacists for 2016, 2017 & 2018 and a Core Lecturer for the European School of Oncology.
He is part of the British Medical Journal “Round Table” group on Biosimilars as well as a faculty member for the DIA Regulators Meeting on Biosimilars. He has been an adviser on medicines and biosimilars policy to several national health systems – both in the EU and beyond.
Paul Cornes has received travel costs to attend meetings and/or received speaker fees from Accord Healthcare; Astro; Biogen; the European Commission; the Global Academy of Health Sciences; GBM-Australia; Mylan, Napp; Pfizer/Hospira; Sandoz.
Dr Mathias Flume is Head of Business Unit Prescription Management at the National Association of Statutory Health Insurance Physicians in Westfalia-Lippe, Germany. He is in charge of the management and development of the Business Unit responsible for all prescriptions of approximately 11,000 doctors, contracting with sick funds etc. and his professional interest focuses on the assessment of innovative drugs and their implementation in regional prescription management.
Dr Flume has also worked as a consultant focusing on German and European HTA topics. He has extensive experience with AMNOG process, dossier reviews and support in the development of clinical trial designs from a HTA perspective.
He studied Pharmacy at the University of Muenster and obtained a PhD in 2001. In 2008 he obtained an executive MBA at the Kellogg School of Management, Chicago, USA and WHU-Otto Beisheim School of Management in Vallendar, Germany.
Dr. Flume received honoraria (Iqvia, CBP) for participation in the following activities between 2016-2019, related to biosimilars:
- Market research interviews
- One day advisory boards around biosimilars
- No continuous relationship to any manufacturer of biologics
Dr Huub Schellekens MD, PhD is emeritus professor of Pharmaceutical Biotechnology at Utrecht University in the Netherlands. He studied medicine at Erasmus University in Rotterdam, The Netherlands ( 1967-1973), where he also did his training in Medical Microbiology (1976-1980) and received his PhD. in 1980.
His work focuses on the preclinical development of biopharmaceuticals and he has published more than 400 papers in peer reviewed international journals, concerning many aspects of the development of therapeutic proteins. Lately, his work has included the immunogenicity of protein drugs and the disadvantages of biosimilars and non-biologic complex drugs. He is also active in developing programs to provide affordable biopharmaceuticals in the developed world and low and middle-income countries.
Prior to joining Utrecht University, Dr Schellekens was deputy director of the Dutch Primate Center, director of Medscand Ingeny and medical microbiologist at the Reinier de Graaf Hospital, Delft, the Netherlands.
Huub Schellekens has received speaker fees from Sandoz, Pfizer, Biocon, Dr Reddy and consultant fees from Sandoz USA.