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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Q&A with FDA: Switching Between Biosimilars and Their Reference Counterparts with Dr. Sarah Yim

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Tue, 5/7/24: 12:00 AM EDT
Ends On: Thu, 5/6/27: 12:00 AM EDT
Type: Enduring Material
Credits: 0.5
Description: This enduring material focuses on reference biologics, biosimilars, and interchangeable biosimilars, and the distinctions between the three classifications. The presenters will discuss how biosimilars can achieve interchangeability status and address concerns that healthcare providers may have when switching their patients between different biosimilar products.
Objectives:
  • Describe the data requirements to support biosimilarity and to determine interchangeability.
  • Recognize the difference between a reference biologic, a biosimilar, and an interchangeable biosimilar.
  • Discuss the safety outcomes of switching patients between different biosimilar products.
Additional Information: Review the Activity Announcement for additional details: Announcement Form