The FDA’s Center for Drug Evaluation and Research’s Office of Therapeutic Biologics and Biosimilars (OTBB) has created curriculum materials to help educators improve understanding about biologics, including biosimilars among students in health care professional degree programs. The resources page includes four sections of resources materials:
- Level 1: Foundational Concepts – Provides downloadable documents including an overview of key basic concepts, information sheets, and specific discussion questions.
- Level 2: Regulatory and Scientific Concepts – Provides a downloadable presentation related to the approval process and prescribing of biosimilar products. Information sheets and specific discussion questions are also available for download.
- Videos – Includes videos on manufacturing, variability, the approval process, and interchangeability.
- Exercises – Designed to help individuals navigate the Purple Book, understand biosimilar labeling, and understand how biosimilars may be included in a formulary.
The toolkit also provides a handful of additional resources from related FDA sources.