U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Types of Applications
  6. Therapeutic Biologics Applications (BLA)
  7. Biosimilars
  8. Curriculum Materials for Health Care Degree Programs | Biosimilars
  1. Biosimilars

Curriculum Materials for Health Care Degree Programs | Biosimilars

FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing professionals, to improve understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States. The Resource Guide for Teaching Faculty provides information for instructors who would like to incorporate topics related to biosimilar and interchangeable biosimilar products into the education and training they provide students.

Explore FDA’s curriculum materials for health care programs.


Level 1: Foundational Concepts

This section provides a high-level overview of biosimilar and interchangeable biosimilar products and describes how these products fit into the broader category of biological therapies. Materials discuss the following topics:

  • The availability of biosimilar and interchangeable biosimilar products in the U.S. health care market
  • The role of health care professionals in prescribing biosimilars
  • Information on interchangeability
 

Level 2: Regulatory and Scientific Concepts

This section provides a more in-depth look at scientific and regulatory topics related to biosimilars and their practical applications. Materials discuss the following topics:

  • The commonalities between biosimilars and reference biological products
  • The approval pathways for biological products
  • Inherent variations in all biological products
  • Information related to prescribing biosimilar and interchangeable biosimilar products

Videos

Manufacturing and Cell Line

Critical Attributes and Variability

 

Biosimilar Approval Process

Interchangeability

 

Comparative Analytical Assessment

Totality of the Evidence

 

Using the Purple Book

Procedural Purple Book

Exercises

Explore biological products, biosimilars products, and interchangeable biosimilar products concepts through the following engaging activities:


Additional Resources

Learn more about biological products, biosimilars, and interchangeable biosimilars from our additional sources:

Back to Top