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  8. Curriculum Materials for Health Care Degree Programs | Biosimilars
  1. Biosimilars

Curriculum Materials for Health Care Degree Programs | Biosimilars

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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 (PDF - 381 KB) 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

Presentation Deck

The following presentation deck provide an overview of key basic concepts related to biologics, biosimilars, and interchangeable products and considerations for prescribing decisions: Level 1 Biosimilar and Interchangeable Products Foundational Concepts (PPT - 5 MB)

Information Sheets

Case Study: What Is a Biosimilar?

An RN in primary care has learned of a new term, biosimilars, from patients and in his reading. He explores the connections between reference products and biosimilars.

View and download information sheets on the following topics:

Discussion Questions

View and download our discussion questions that correspond to Level 1: Foundational Concepts (PDF - 373 KB).


Level 2: Regulatory and Scientific Concepts

Case Study: Biosimilars in Patient Care

A prescriber considers a newly available biosimilar medicine for a patient. She explores publicly available information on the biosimilar, as well as experience from peers in her medical field.

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

Presentation Deck

This following presentation deck provides key information on the review and approval process for biosimilars and interchangeable biosimilar products and on prescribing these products: Level 2 Biosimilars and Interchangeable Biosimilars.Regulatory and Scientific Concepts (PPT - 5 KB)

Case Study: Interchangeable Products

A pharmacist considers switching a patient’s current medication to an interchangeable biosimilar product, because the patient’s new insurance carrier no longer covers their current medication. She explores information on the interchangeable biosimilar product.

Information Sheets

View and download information sheets on the following topics:

Discussion Questions

View and download our discussion questions that correspond to Level 2: Regulatory and Scientific Concepts (PDF - 391 KB).


Videos

Exercises

Learn more about biological products, biosimilars products, and interchangeable biosimilar products through the following engaging activities:


Additional FDA Resources

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

 
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