Emerging Technologies

Biosimilar and Interchangeable Biological Products: An Overview of Scientific Concepts and Practical Resources

This webinar provides an overview of the scientific concepts about biological products and the scientific and regulatory basis for the biosimilar and interchangeable biosimilar approval pathway. Explore the science of biological molecules, including size, complexity, and structure.  In addition, we will review practical information regarding the use of these products, such as labeling, terminology, and pharmacy substitution. Also, demonstrate the functionality of the Purple Book Database and get an overview of FDA’s educational materials available for healthcare professionals and patients. 

Learning Objectives

Pharmacist & Technicians

  1. Describe how biologics differ from small molecules (size, complexity, manufacturing) and explain why some biologics cannot be copied exactly. 
  2. Compare and contrast the development, statutory requirements, and approval process for new biologics and for biosimilars/interchangeables.  
  3. Compare and contrast the requirements for generics and biosimilars/interchangeables.  
  4. Describe the U.S. Food and Drug Administration's (FDA) educational resources available for healthcare providers to learn more about biosimilar and interchangeable products.  
  5. Explain how to use the Purple Book Database of Licensed Biological Products 

Speaker

  • Nina Brahme, PhD, MPH
  • Shelley Skibinski, PharmD
  • Sarah Ikenberry, MA
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