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Updated: May 1, 2026
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
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Biosimilars in practice: best-practice immunogenicity assessment and switching/interchangeability strategies for
Khawla Abouhait1, Ahmad Z Al Meslamani1
1College of Pharmacy, Al Ain University, Abu Dhabi, United Arab Emirates.
Bioanalysis
|April 30, 2026
Summary
Biosimilars offer cost-effective, clinically equivalent biologic medicines. Pharmacy-led stewardship can ensure safe switching and interchangeability, maintaining patient safety and treatment efficacy.
Area of Science:
- Pharmacoeconomics
- Immunology
- Drug Development
Background:
- Biosimilars increase access to biologic therapies by offering lower-cost, clinically equivalent alternatives.
- Real-world application necessitates robust immunogenicity surveillance and clear pathways for switching and interchangeability.
- Current regulatory trends favor interchangeability, simplifying evidence requirements.
Purpose of the Study:
- To review the evidence supporting biosimilar clinical equivalence and the impact of switching.
- To propose standardized, patient-centered switching and interchangeability pathways.
- To outline a pharmacy-led stewardship toolkit for safe switching.
Main Methods:
- Narrative review of literature from major scientific databases (PubMed/MEDLINE, Embase, Scopus, Web of Science) and Google Scholar.
- Inclusion of studies published between January 1, 2019, and December 1, 2025.
- Analysis of data on biosimilar efficacy, safety, immunogenicity, and switching outcomes.
Main Results:
- Biosimilars and reference biologics demonstrate clinical equivalence.
- Switching between biosimilars and reference biologics generally has no significant impact on population-level safety or immunogenicity.
- A small patient subset may experience issues related to anti-drug antibodies (ADA) or neutralizing antibodies (NAb).
Conclusions:
- Standardized, pharmacy-led switching and interchangeability pathways are crucial for real-world biosimilar use.
- A comprehensive toolkit, including risk-stratified immunogenicity testing and action algorithms, can manage potential adverse events.
- The focus is shifting from proving switching to safely operating switching and interchangeability for broader biosimilar adoption.
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