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Drug Products: Biologics, Biosimilars and Interchangeables

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Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

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Extrapolation: Experience gained from original biologics.

Luisa-Fernanda Rojas-Chavarro¹, Fernando de Mora¹

¹Department of Pharmacology, Therapeutics and Toxicology, Universidad Autónoma de Barcelona, Spain.

Drug Discovery Today

|May 22, 2021

Summary

This summary is machine-generated.

Extrapolation is a valid scientific approach for approving biosimilars, mirroring its use in original biologic lifecycle changes. Analytical comparisons reliably predict clinical equivalence, reassuring healthcare professionals about biosimilar safety and efficacy.

Keywords:

Adalimumab Biologic Biosimilar Canakinumab Darbepoetin Extrapolation Manufacturing change Omalizumab Trastuzumab

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Area of Science:

Biopharmaceutical Science
Regulatory Science
Clinical Equivalence Assessment

Background:

Biological medicines (biologics) can undergo modifications during their commercial lifecycle.
These modifications may unintentionally increase inherent physicochemical variability.
Assessing clinical equivalence between different versions is crucial.

Purpose of the Study:

To analyze the scientific basis and historical precedent for using extrapolation in biologic approvals.
To address controversies surrounding biosimilar approval via extrapolation.
To provide reassurance to healthcare professionals regarding biosimilar extrapolation.

Main Methods:

Comprehensive analysis of existing literature and historical data on original biologic approvals.
Review of cases where original biologic versions were approved for new indications without patient trials.
Comparison of analytical assessment sensitivity versus clinical trials for predicting equivalence.

Main Results:

Extrapolation has been historically applied to approve new versions of original biologics in different indications.
Analytical comparison is a sensitive method for predicting clinical equivalence between biologic versions.
Cases exist where original biologics were approved in new indications based on extrapolation.

Conclusions:

The principle of extrapolation, proven valid for original biologics, is equally applicable to biosimilars.
Analytical comparison provides a robust foundation for extrapolation, supporting biosimilar regulatory pathways.
Healthcare professionals can be confident in the extrapolation of data for biosimilar approvals.