As comparative clinical studies can be costly and time consuming, the US Food and Drug Administration (FDA), is currently conducting research to inform the agency’s thinking on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. This, according to the agency could either streamline or negate the need for comparative clinical studies.
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 FDA, at the DIA Biosimilars Conference. In his presentation, Dr Stein outlined the ‘positioning’ of PD biomarkers in the evaluation of biosimilarity [1].
According to FDA’s stepwise approach to demonstrating biosimilarity, the process should begin with the establishment of an analytically ‘highly similar’ foundation from comparative analytical studies (product quality), followed by animal or in vitro studies and clinical studies assessing safety/immunogenicity, pharmacokinetic (PK) similarity and, when appropriate, PD similarity. Additional comparative clinical studies may be necessary to address residual uncertainties that remain to support a demonstration that there are no clinically meaningful differences between the proposed biosimilar and reference product in terms of the safety, purity and potency of the product.
Dr Stein outlined how PD biomarkers fit into this stepwise approach in Table 1.
Table 1: PD biomarkers in the evaluation of 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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