Earlier today, FDA updated the Biosimilar Curriculum Toolkit. This toolkit was created to help educate practicing professionals and professional students in healthcare degree programs for medicine, nursing, pharmacy, and physician associates about the regulatory approval pathway for biosimilar and interchangeable biosimilar products. More specifically, this toolkit contains the following curriculum materials for healthcare programs:
- Level 1: Foundational Concepts - Describes how biosimilars fit into the broader category of therapeutic biological products, the availability of biosimilars and interchangeable biosimilars in the U.S., the role of providers in prescribing, and information on interchangeability.
- Level 2: Regulatory and Scientific Concepts - Provides an in-depth look at scientific and regulatory topics related to biosimilars and their practical applications, including the relationship between biosimilars and reference products, the different approval pathways for biologics, inherent variations in all biologics, and information related to prescribing biosimilars.
- Additional Resources – Contains presentation decks that serve as the core for the other educational materials as well as explanatory videos, information sheets, case studies, and discussion questions.
In addition to these curriculum materials, FDA also provided a Resource Guide for Teaching Faculty that provides information that instructors can use to incorporate topics related to biosimilar and interchangeable biosimilar products into education and training.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
