eLearning module: Clinical development

In this expert authored eLearning module, Professor Huub Schellekens looks at the clinical development process of biosimilars, particularly the importance of clinical trials to demonstrate biosimilarity.

This 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 ensure you complete the evaluation form at the end of the module. Credits are only commensurate with completion of all of the designated modules.

Learning objectives

On completion of the eLearning module, you will be able to:

  • Explain what is “Totality of Evidence” and why it is important to prove biosimilarity.
  • Explain what type of clinical trials are important in the clinical development process of biosimilars and how they contribute to prove biosimilarity.

Target audience

All medical oncologists, specialist nurses, and allied healthcare professionals working with patients for whom biosimilars may represent a treatment option.

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Dr Huub Schellekens

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.

Disclosures

Huub Schellekens has received speaker fees from Sandoz, Pfizer, Biocon, Dr Reddy and consultant fees from Sandoz USA.