eLearning module: Immunogenicity

In this expert authored eLearning module,  Professor Huub Schellekens explains 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 module will take up to 20 minutes to complete.

Learning objectives

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

  • Explain the factors that contribute to, and the consequences of, immunogenicity of biosimilars.
  • Discuss the design and importance of immunogenicity assessments during the development of biosimilars.

Target audience

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

Authored by Professor Huub Schellekens

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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.

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