Related Experiment Video
Updated: Apr 3, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Biosimilars - terms of use
Paul Declerck1, Håkan Mellstedt2, Silvio Danese3
1a a Department of Pharmaceutical and Pharmacological Sciences , KU Leuven, University of Leuven , Leuven , Belgium.
Abstract:
The impending expiry of the patent on a number of leading biologic drugs has led to a surge in the development of 'biosimilar' or 'follow-on' products. However, in contrast to generic small-molecule medicines, biosimilars are not identical to their reference products. The differences and complexities surrounding both the molecular structure and the manufacturing process for biologics and biosimilars have resulted in a lack of clarity regarding the terms used in different parts of the world to define various aspects of development and utilization such as regulatory approval, pharmacovigilance, interchangeability and treatment-naivety. This makes quantitative evaluation of biosimilars a great challenge to both the scientific community and regulatory agencies. This manuscript attempts to clarify the terms used and address an important knowledge gap which is currently resulting in an increasing rush to position biosimilars for certain indications and patients in the absence of agreed upon definitions.
More Related Videos
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Bioequivalence: Overview
Bioequivalence of Drugs: Drugs with Multiple Indications
Bioequivalence studies: Biowaivers
Pharmaceutical Equivalents
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

