During the DIA Biosimilars Conference 2021 a presentation entitled ‘An update on the FDA biosimilar program: progress and directions, 2021’ was given by Dr Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA). In this presentation, Dr Stein outlined the role that pharmacodynamic (PD) biomarkers have with respect to biosimilars [1].
He outlined that PD biomarkers have an important role in proving biosimilarity by evaluating residual uncertainty. This starts with analytic structural assessment, which is the central component of the biosimilarity evaluation. Each ‘step’ of the process is then evaluated to determine the extent of residual uncertainty that needs to be addressed in subsequent steps. With the increasing quality (and quantity with orthogonal approaches) of analytical assessments, use of analytical assessments plus pharmacokinetic (PK)/PD studies may be sufficient to support biosimilarity.
According to Dr Stein, this means that biosimilars ‘may be approved based on PK and PD biomarker data without a comparative clinical efficacy study’. This would mean that long, expensive, comparative clinical efficacy studies could be replaced by shorter and less costly clinical development.
In addition, evaluation of PK and PD similarity can have the added advantage of being more sensitive than clinical efficacy endpoints in detecting differences, should differences exist.
Considerations to be taken into account for PD biomarker assessment include criteria, correlation and residual uncertainty:
Criteria
Criteria for PD biomarkers intended to support a demonstration of biosimilarity are inherently different from criteria for surrogate biomarkers used to support new drug approvals.
Correlation
As the purpose is to confirm similarity instead of independently establishing safety and effectiveness, a correlation between the PD biomarker and clinical outcomes is not a requirement.
Residual uncertainties
Biosimilar development programmes use PD biomarker similarity studies to address residual uncertainties about biosimilarity.
Conflict of interest
The author of the presentation [1] did not provide any conflict-of-interest statement.
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Reference
1. An update on the FDA biosimilar program: progress and directions, 2021. DIA Biosimilars, Virtual Conference, 5-6 October 2021.
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