The Reagan-Udall Foundation for the FDA is conducting a series of six closed-door virtual roundtable conversations with biosimilar developers to explore emerging areas of regulatory science and to create a space for active discussion and exploration between FDA and biosimilar developers. (Topics and dates listed below.) Each 90-minute roundtable will particularly include developers who may have had limited engagement with FDA. At the completion of the series, the Foundation will publish a summary of shared learnings and acknowledge the names of the organizations that participated. To ensure broad representation with limited space, interested developers should submit their request to participate via email to biosimilars@reaganudall.org by Monday, July 22, 2024.
| August 6, 2024 | Achieving Analytical Similarity |
|---|---|
| August 27, 2024 | Leveraging Analytics to Inform Remainder of Biosimilar Development |
| September 18, 2024 | Achieving Pharmacokinetic Similarity |
| October 8, 2024 | Leveraging Pharmacokinetics and/or Pharmacodynamics to Inform Remainder of Biosimilar Development |
| October 30, 2024 | Conducting Immunogenicity Risk Assessments and Evaluation |
| November 19, 2024 | Emerging Themes from Previous Roundtables |
Topics Subject to Change
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $150,000 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit FDA.gov.