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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

Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources

Step Status
Educational Content
Starts On: Fri, 2/18/22: 12:00 AM EST
Ends On: Tue, 12/31/24: 11:45 PM EST
Type: Enduring Material
Credits: 1
Description: This webinar will provide an intermediate overview of the scientific and regulatory basis for the biosimilar and interchangeable biosimilar approval pathway. The webinar will build on past biosimilar webinars and further explores the science of biological molecules, including size, complexity, and inherent variation. 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 resources available to health care professionals such as the Purple Book Database.
  • Describe how biologics differ from small molecules (size, complexity, inherent variation) and explain why some biologics cannot be copied exactly.
  • Compare and contrast the development, statutory requirements, and approval process for new biologics and for biosimilars/interchangeables.
  • Differentiate between the requirements for FDA approval of generics and biosimilars/interchangeables and discuss the availability of insulin products.
  • Review case studies of approved biosimilar and interchangeable products.
  • 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: Biosimilarslides