PD biomarkers for biosimilar development and approval

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At the DIA Biosimilars Conference 2021, 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’ [1].

Biomarker select V21K26

His presentation included slides that were also presented at a two-day virtual public workshop held by Duke-Margolis and FDA. The virtual public workshop, which was held on 20‒21 September 2021 was a forum for regulators, biopharmaceutical developers and academic researchers to discuss the current and future role of pharmacodynamic (PD) biomarkers in improving the efficiency of biosimilar product development and approval.

Comparative clinical efficacy study(ies) may not be needed to establish biosimilarity between investigational biosimilars and their reference products if there are sufficient data from other comparative studies including human pharmacokinetic (PK) and PD studies [2]. When available, PD biomarkers can demonstrate the characteristics of a biosimilar’s target effects, helping reduce residual uncertainty about whether there are no clinically meaningful differences between a biosimilar and its reference product.

However, few biosimilars have been approved that leverage PD biomarker data without comparative clinical efficacy studies. Although FDA has published guidance on PD biomarker selection and general study design considerations [2], additional regulatory clarity on the use of PD biomarkers to support demonstrations of biosimilarity might facilitate additional biosimilar development and approval. Therefore, FDA is working to advance an evidentiary framework and methodology for identifying, characterizing, and applying PD biomarkers to assess biosimilarity so patients can access safe, effective, and lower cost biosimilars sooner.

In his presentation, Dr Stein outlined the progress and directions possible for PD biomarkers to be used for biosimilar development and approval.

In the following series of three articles the role of PD biomarkers in biosimilarity, the positioning of PD biomarkers in evaluating biosimilarity and key considerations for PD biomarkers in evaluating biosimilarity are presented in more detail.

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

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1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 26]. Available from: www.gabionline.net/guidelines/US-guidelines-for-biosimilars
2. An update on the FDA biosimilar program: progress and directions, 2021. DIA Biosimilars, Virtual Conference, 5-6 October 2021.

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Source: Duke, US FDA

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