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  6. Therapeutic Biologics Program (TBP)
  1. CDER Offices and Divisions

Therapeutic Biologics Program (TBP)

Who We Are

Therapeutic Biologics Program (TBP) is in the Immediate Office within the Office of Clinical Pharmacology (OCP). TBP consists of scientists with broad clinical pharmacology knowledge and specialized experience in biologics and biosimilars.

What We Do

The TBP team facilitates the development and approval of novel biologics and biosimilars through multiple activities:

  • Lead or contribute to policy development and revision;
  • Provide consult to review team or participate in review;
  • Conduct research to address review issues and knowledge gap;
  • Collaborate internally and externally to enhance communication and advance science.
A circular graphic representing the four focus areas of the Therapeutic Biologics Program (TBP). At the center is a circle labeled "Therapeutic Biologics Program (TBP)." Surrounding this are four sections: "Developing clear policies" with a scale icon, "Enhancing excellence in review" with a lightbulb icon, "Building collaboration and outreach" with a handshake icon, and "Facilitating knowledge sharing" with an open book icon. Each section highlights a key objective of the TBP.

 

Contact Information

Therapeutic Biologics Program
Office of Clinical Pharmacology
Office of Translational Science
Center for Drug Evaluation and Drug Research
U.S. Food & Drug Administration
Email: therapeuticbiologicsprogram@fda.hhs.gov

Highlighted Publications

FDA Guidances Related to Clinical Pharmacology of Biologics and Biosimilars

2024

2023

2022

2021

2019

2014

2024

2023

2021

2019

2018

2016

Please refer to the FDA guidance search website and the FDA guidance snapshot and podcast website for more information.

Collaboration and Outreach

This workshop explored the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe.

  • Date: February 26, 2024
  • Format: Hybrid

Learn More

FDA researchers are investigating the utility of pharmacodynamic, or PD, biomarkers to demonstrate biosimilarity. This research can potentially help developers demonstrate that their proposed product is biosimilar to, or interchangeable with an FDA-approved biological product, and improve the efficiency of biosimilar development.

Learn More

In this webinar, leading academic clinicians with specialties in several therapeutic areas shared their experience with biosimilars, their perspectives on how to improve the efficiency of biosimilar evaluations, and how to increase biosimilar adoption, including the role of clinical pharmacology.

  • Date: April 13, 2022
  • Format: Virtual

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This virtual public workshop 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.

  • Date: September 20-21, 2021
  • Format: Virtual

Learn More

Additional Resources



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