Safety assessment of biosimilars in Europe: a regulatory perspective

Abstract

Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines Agency's 'Guideline for similar biological medicinal products containing biotechnology-derived proteins as active substances: non-clinical and clinical issues', which is currently under revision, forms the basis for the topics discussed in this paper. Topics discussed include adverse events related to an exaggerated pharmacology, immunogenicity including assay development, extrapolation of indications in relation to safety assessment and pharmacovigilance.