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  6. FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers - June 20, 2023
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FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers - June 20, 2023

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, June 20, 2023, CDER's Office of Communication, Division of Drug Information (DDI) hosted a webinar titled: FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers. This webinar discussed 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 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 the Purple Book Database and highlight resources available to health care providers about biosimilars.

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Download Presentation Slides: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers (PDF - 5.39MB)

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