FDA Drug Topics: Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources – January 25, 2022
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!
On Tuesday, January 25, 2022, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources. This webinar provided an intermediate overview of the scientific and regulatory basis for the biosimilar and interchangeable biosimilar approval pathway. The webinar built on past biosimilar webinars and further explores the science of biological molecules, including size, complexity, and inherent variation. In addition, we discussed the use of these products, including labeling, terminology, and pharmacy substitution. To enhance understanding, we reviewed case studies to highlight the data that can support biosimilarity and interchangeability. This webinar also demonstrated the functionality of resources available to health care professionals such as the Purple Book Database.
Register Here: https://collaboration.fda.gov/ddi012522/event/registration.html
Download Presentation Slides: Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources (PDF - 3.22MB)
Activity Outline and Continuing Education Information: Biosimilar and Interchangeable Biosimilars: Review of Scientific Concepts, Case Studies, and Resources (PDF - 894KB)
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