FDA and Duke-Margolis Announce a Public Workshop Entitled “Pharmacodynamic Biomarkers for Biosimilar Development and Approval” for September 20 – 21, 2021

Author: [AUTHOR] Published on 7/23/2021 5:00:00 AM

FDA and Duke-Margolis Announce a Public Workshop Entitled “Pharmacodynamic Biomarkers for Biosimilar Development and Approval” for September 20 – 21, 2021

The US Food and Drug Administration (FDA) in collaboration with Duke-Margolis will host a two-day virtual public workshop entitled “Pharmacodynamic Biomarkers for Biosimilar Development and Approval” on September 20 – 21, 2021. This public workshop is 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.

Biologic medicines play an important role in the treatment of many serious illnesses; however, biologic medicines can be costly. With biosimilars (biologic medicines that are highly similar to and have no clinically meaningful differences from existing FDA‐approved reference products), drug developers can leverage the safety and effectiveness data of reference products to support the approval of biosimilars, potentially providing access to lower cost treatments.

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.1,2 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 the 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 demonstration of biosimilarity might facilitate additional biosimilar development and approval. Therefore, the 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.

Workshop Objectives:
  • Discuss the current and potential future state of leveraging PD biomarkers for biosimilar development and approval
  • Summarize FDA’s initiatives to advance biosimilar development
  • Describe stakeholders’ experience with PD biomarkers in biosimilar development
  • Explain research efforts to promote a broader application of PD biomarkers in biosimilar development
The date, time, and location of the workshop are as follows:

Date: September 20 – 21, 2021
Time: 10:00 AM – 2:30 PM ET (both dates)
Location: Virtual

Meeting Information and Registration: This workshop is open to the public with no cost to attend, but registration is required. To see the agenda and register, please visit: https://healthpolicy.duke.edu/events/biosimilar

Questions: For questions regarding this event, please send an email to luke.durocher@duke.edu

1 US Food and Drug Administration. FDA guidance: scientific considerations in demonstrating biosimilarity to a reference product (2015). Accessed June 25, 2021.
2 US Food and Drug Administration. FDA guidance: clinical pharmacology data to support a demonstration of biosimilarity to a reference product (2016). Accessed June 25, 2021.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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