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Updated: Mar 18, 2026

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

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

Published on: May 4, 2017

Biosimilars: Extrapolation for oncology.

Giuseppe Curigliano¹, Darran P O'Connor², Julie A Rosenberg³

¹European Institute of Oncology, Division of Experimental Therapeutics, Milano, Italy.

Critical Reviews in Oncology/Hematology

|June 30, 2016

Summary

This summary is machine-generated.

Biosimilars are highly similar biologics to reference products. Indication extrapolation for biosimilars requires scientific justification based on mechanism of action and data.

Keywords:

Biosimilar Cancer Extrapolation Monoclonal antibody

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Area of Science:

Biologics and biosimilars
Pharmacology
Regulatory science

Background:

Biosimilars are biological products highly similar to reference products regarding purity, safety, and efficacy.
Extrapolation of indications for biosimilars is permissible for therapeutic areas of the reference product not directly studied.
Scientific justification is mandatory for biosimilar indication extrapolation.

Purpose of the Study:

To outline the data requirements for establishing biosimilarity.
To emphasize the scientific basis for indication extrapolation of biosimilars.
To highlight the role of mechanism of action in biosimilar approval.

Main Methods:

Review of regulatory guidelines and scientific literature on biosimilar development.
Analysis of data requirements for demonstrating high similarity.
Evaluation of principles supporting extrapolation of therapeutic indications.

Main Results:

Detailed data are necessary to confirm high similarity between biosimilar and reference product.
Extrapolation relies on scientific rationale, including shared mechanism of action.
Comparative clinical studies are not always required for every indication.

Conclusions:

Establishing biosimilarity requires comprehensive data packages.
Indication extrapolation is a scientifically sound process when justified.
Understanding the mechanism of action is crucial for biosimilar regulatory approval.