Immunogenicity of Innovative and Biosimilar Medicinal Products
Erik Doevendans
Technical Head (NL) & Principal Consultant
Scendea Authors:
Dr. Guangxi Feng, Dr. Matt (Jiun-Ming) Wu
Protein Science Group
Chime Biologics Authors:
Introduction
The first regulation and guidance for copy biotech products (biosimilars), pioneered by the EMA, not only enabled the introduction of biosimilars in the EU, but also were a model for regulatory regions worldwide.
Currently, over 100 biosimilars are used in clinical practice and the total clinical experience with biosimilar medicines exceeds two billion treatment days [Mysler et al, 2021]. There are around forty biosimilar of nine originator mAbs authorized in the EU and US [September 2023, EMA website/FDA] and there is no evidence of differences in safety, immunogenicity, and efficacy between biosimilar and originator products [a.o. Bielsky et al, 2019]. Recent data show that there are no concerns with interchangeability either…