Safety assessment of biosimilars in Europe: a regulatory perspective

Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc

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 […]

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