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Pharmacodynamic Biomarkers Evidentiary Considerations for Biosimilar Development and Approval

David G Strauss¹, Yow-Ming Wang², Jeffry Florian¹

¹Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Clinical Pharmacology and Therapeutics

|September 30, 2022

Summary

Pharmacodynamic (PD) biomarkers can streamline the development of biosimilars, making safe, effective, and affordable treatments more accessible. Increased use of PD biomarkers can reduce costs and time in biosimilar approvals.

Area of Science:

Biopharmaceutical science
Regulatory science
Biomarker development

Background:

Biosimilars offer crucial alternatives to reference products, improving patient access to treatments.
Current biosimilar development can be lengthy and expensive.
Pharmacodynamic (PD) biomarkers offer a potential method to streamline biosimilar development.

Purpose of the Study:

To review the current use of PD biomarkers in biosimilar development.
To discuss evidentiary and study design considerations for PD biomarkers in biosimilars.
To summarize regulatory science activities supporting PD biomarker use in biosimilars.

Main Methods:

Review of existing literature on PD biomarker use in biosimilar approvals.
Discussion of evidentiary standards for PD biomarkers.
Analysis of clinical study designs for pharmacokinetic and PD assessments.
Summary of FDA's regulatory science initiatives.

Main Results:

PD biomarkers have been underutilized in biosimilar approvals to date.
There is significant potential to use PD biomarkers, including novel ones, to replace or supplement clinical efficacy studies.
FDA is actively researching PD biomarkers to support biosimilar development.

Conclusions:

Optimizing the use of PD biomarkers can accelerate the availability of biosimilar treatments.
Further understanding of evidentiary requirements and study designs is needed.
Regulatory science efforts are crucial for advancing PD biomarker application in biosimilars.

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