Curriculum Materials for Health Care Degree Programs | Biosimilars
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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
- Level 2: Regulatory and Scientific Concepts
- Videos
- Additional FDA Resources
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-4.5MB)
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:
- Biological Products, Biosimilars Products, and Interchangeable Biosimilar Products (PDF - 223 KB)
- Generics and Biosimilars (PDF - 250 KB)
- Manufacturing and Variation (PDF - 411KB)
- Biosimilar Regulatory Approval Pathway (PDF - 189 KB)
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:
- Variation in Biological Products (PDF - 248 KB)
- Comparative Clinical Studies (PDF - 324 KB)
- Prescribing Biosimilar and Interchangeable Biosimilar Products (PDF - 367 KB)
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:
- Visit https://purplebooksearch.fda.gov/.
- Enter the name of a biological product (i.e., reference, biosimilar, or interchangeable product) in the “Search” section.
- Explore the information. For example, if you searched for a reference product, the “Results” page will provide you with a list of approved products, including the corresponding biosimilar and interchangeable products, if any.
- Note the proprietary name for each biological product listed as well as the non-proprietary name (i.e., core name with a unique four-letter suffix).
- Explore the dosing information, route of administration, license type, and other topics by clicking on each biological product listed.
- Visit https://purplebooksearch.fda.gov/
- Enter the name of a biological product (i.e., reference, biosimilar, or interchangeable product) in the Search section.
- Find the reference product in the Results page. Click “Product Label” to explore the information. Find the respective biosimilar product in the Results page and click on “Product Label” to explore the information.
- Click “Approval Date(s) and History, Letters, Labels, Reviews.”
- Compare and contrast the labeling and prescribing information provided for the reference product and its respective biosimilar product(s) in the “Label (PDF)” section.
- Click on the “Letter,” “Review,” and “Supplement” sections, if applicable for the reference product and biosimilar product(s), for additional information.
- Visit https://purplebooksearch.fda.gov/.
- Enter the name of a biological product (i.e., reference, biosimilar, or interchangeable product) in the Search section.
- Discuss the strategic considerations made by pharmacy and therapeutic (P&T) committees. Evaluations may include:
- Scientific reviews of specific products
- Physiochemical and functional studies demonstrating biosimilarity to the reference product
- Clinical studies demonstrating no clinically meaningful difference from the reference product
- Extrapolation data, if applicable
- Additional switching studies, if applicable, for interchangeable designation
- What the financial assessment may include and how P&T committees use it in their evaluations
- What the operational assessment may include and how P&T committees use it in their evaluations
- Scientific reviews of specific products
*Note: While the financial assessment and operational assessment are important considerations for P&T committees, these topics are beyond FDA’s purview.
Additional FDA Resources
Learn more about biological products, biosimilars, and interchangeable biosimilars from our additional sources:
- Health Care Provider Materials
- Patient Materials
- Purple Book: Database of Licensed Biological Products
- Drugs@FDA: FDA-approved drugs
- FDA guidance documents (search for “biosimilars”)
- Advisory committee materials for biosimilars