Key considerations for PD biomarkers in evaluating biosimilarity

INICIO/Informes | Posted 17/12/2021 post-comment0 Post your comment

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.

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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), gave a presentation entitled ‘An update on the FDA biosimilar program: progress and directions, 2021’ during the DIA Biosimilars Conference 2021. In his presentation Dr Stein outlined the key considerations for PD biomarkers in the evaluation of biosimilarity [1].

According to Dr Stein, the key points when considering PD biomarkers in the evaluation of biosimilarity are that:
• PD biomarkers for biosimilars do not need to be surrogate endpoints for clinical efficacy outcomes
• Characterization of PD biomarkers according to the 5 key characteristics is critical to assess their suitability
• A single clinical pharmacology study can assess both PK and PD similarity if designed appropriately
• Utilization of PD biomarkers can eliminate the need for comparative clinical efficacy studies, streamlining biosimilar development

In its guidance, FDA has described five characteristics for PD biomarkers to assist sponsors planning to use PD biomarkers as a component of a biosimilar development programme [2], see Figure 1.

GW 4689G 4 Stein_Fig1 V21L17LT

Conflict of interest
The author of the presentation [1] did not provide any conflict-of-interest statement.

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1. An update on the FDA biosimilar program: progress and directions, 2021. DIA Biosimilars, Virtual Conference, 5-6 October 2021.
2. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from:
3. Li J, Florian J, Campbell E, et al. Advancing biosimilar development using pharmacodynamic biomarkers in clinical pharmacology studies. Clin Pharmacol Ther. 2020;107(1):40-2.

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Source: Duke, US FDA

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