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  5. Office of Therapeutic Biologics and Biosimilars (OTBB)
  1. Center for Drug Evaluation and Research | CDER

Office of Therapeutic Biologics and Biosimilars (OTBB)

Mission

To support the development and approval of high quality, safe, and effective biosimilar and interchangeable biologic products for the American public.

Overview

The Office of Therapeutic Biologics and Biosimilars (OTBB) coordinates and supports all biosimilar and interchangeable product activities in the Center for Drug Evaluation and Research (CDER). OTBB provides infrastructure and specialized resources to enhance the BsUFA program and support the objectives included in the Biosimilars Action Plan (BAP), as well as addressing any additional biosimilar or biological product issues.

Additional OTBB responsibilities

  • Streamlining biosimilar product development and review activities
  • Ensuring consistency in the application of FDA’s scientific and regulatory policy to biosimilar and other biological product development and review
  • Coordinating and managing policy development, implementation, and reporting
  • Collaborating Agency-wide to support efforts related to biosimilars and certain biological product issues (e.g., policy, BLA review)
  • Leading international regulatory authority engagement related to biosimilars
  • Supporting external activities for biosimilars and other biologic products, including effective communications to stakeholders
  • Developing policy, procedures and staff training to support BsUFA and the BPCI Act
  • Managing CDER’s Biosimilar Review Committee (BRC) and the CDER/CBER Biosimilar Policy Council (BPC)

Additional Information

Questions?

For general questions about biosimilar and interchangeable products, please email [email protected].  

For questions regarding a product development program or 351(k) BLA for which you are the sponsor, applicant, or authorized representative, please contact the regulatory project manager assigned to the application.



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