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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

Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Wed, 8/23/23: 12:00 AM EDT
Ends On: Fri, 8/21/26: 11:45 PM EDT
Type: Enduring Material
Credits: 1
Description: This online learning activity will discuss the science of biological products, including size, complexity, and variation. We will describe commonalities between biosimilars and reference biological products and differences in the approval pathways, with an in-depth explanation of the scientific and regulatory concepts for biosimilars and interchangeable biosimilars. In addition, we will discuss the use of these products, including labeling, terminology, and pharmacy substitution. To enhance understanding, we will review case studies to highlight the data that can support biosimilarity and interchangeability. This webinar will also demonstrate the functionality of the Purple Book Database and highlight resources available to health care providers about biosimilars.
Objectives:
  • Review the key definitions, nomenclature, labeling, issues of interchangeability, and similarities and differences between biosimilars and reference biologics.
  • Describe how biologics differ from small molecules (size, complexity, inherent variation) and compare the biosimilar and generic approval pathways.
  • Explain the statutory requirements and approval process for biosimilars and interchangeables.
  • Discuss considerations for prescribing and dispensing biosimilars and interchangeable biosimilars.
  • Summarize the new resources available for health care providers and faculty to learn more about biosimilar and interchangeable products and how to use the Purple Book Database of Licensed Biological Products.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES

For additional information about biosimilar and interchangeable products please visit http://www.fda.gov/biosimilars/

Please visit The Purple Book: Database of Licensed Biological Products for information on biological products, including if products are biosimilar to a reference product.