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Updated: May 12, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

Published on: May 4, 2017

Differential immunogenicity of biosimilar monoclonal antibodies: overrated and overemphasized?

Uwe Gudat1

  • 1Clinical Development and Medical Affairs, Biocon Biologics Ltd., Bangalore, India.

Drug Discovery Today
|May 10, 2026
PubMed

Monoclonal antibodies (mAbs), as biologics and biosimilars, have revolutionized patient care for certain chronic inflammatory and oncological conditions over the past decade. Immunogenicity against these biologic therapeutics is not uncommon and can be associated with adverse reactions, attenuated efficacy, or altered pharmacokinetics (PK). Concerns have been voiced about whether biosimilars are immunologically equivalent to their respective biologics, highlighting the risk of clinically meaningful adverse differential immunogenicity. However, integrating evidence from well-controlled clinical trials, health authority reviews, and real-world monitoring of over 61 biosimilar mAbs of 13 reference biologic mAbs, and accounting for human immune biology, does not support the concerns raised.

Keywords:
anti-drug antibodybiologicsbiosimilarsimmunogenicitymonoclonal antibodies (mAbs)

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