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  6. Therapeutic Biologics Program (TBP)
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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

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


Collaboration and Outreach


Additional Resources




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