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
- Level 2: Regulatory and Scientific Concepts
- Videos
- Additional 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
The Level 1 presentation deck provides an overview of key basic concepts related to biologics, biosimilars, and interchangeable products and considerations for prescribing decisions.
Biological, Biosimilars, and Interchangeable Products
Definitions and distinctions between biological products, reference products, biosimilars, and interchangeable biosimilars.
Biosimilar Regulatory Approval Pathway
Regulatory approval process for biosimilars, detailing the requirements for demonstrating biosimilarity to reference biological products.
Manufacturing and Variation
Complexities of manufacturing biological products, including biosimilars.
Generics and Biosimilars
Differences between generic drugs and biosimilars and their respective approval processes.
Purple Book
How to navigate FDA’s Purple Book and search for FDA-approved biological products, including biosimilars and interchangeable biosimilars.
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.
This case study introduces and explains the concept of biosimilars, their differences from generic drugs, the inherent variations in biological products, and the potential benefits biosimilars offer in U.S. healthcare.
Download Biosimilar Case Study
Insulins
A physician-in-training learns biosimilar insulin products are available in primary care and other everyday clinical settings.
This case study introduces and explains biosimilar and interchangeable insulin products, their transition to the biologics regulatory framework, their impact on patient care and prescribing considerations.
The Level 1 discussion questions are designed to assess knowledge and facilitate understanding of foundational biosimilar concepts, focusing on the relationship between reference products, biosimilars, and interchangeable biosimilar products.
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
The Level 2 presentation deck provides key information on the review and approval process for biosimilars and interchangeable biosimilar products and on prescribing these products.
Variation in Biological Products
Examples of inherent variation in biological products, including reference products and biosimilars, during their manufacturing process due to their complexity and the use of living organisms in production.
Comparative Clinical Studies
Comparative clinical studies may be conducted to ensure that there are no clinically meaningful differences between a biosimilar product and its reference product.
Prescribing Biosimilars and Interchangeables
Considerations for healthcare providers on prescribing and dispensing biosimilar and interchangeable biosimilars and the naming of biological products.
Labeling for Biosimilar and Interchangeable Biosimilar Products
Biosimilar and interchangeable biosimilar labeling, highlighting important considerations for prescribing and dispensing.
Biosimilar Product Quality Attributes
Key physical, chemical, and biological characteristics of biosimilar products that are identified and evaluated.
Comparative Analytical Assessment (CAA) and Product Quality
Information about the comparative analytical assessment, the foundation of the biosimilar approval pathway, and comparisons between a biosimilar and the reference product.
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 case study aims to help healthcare providers understand the clinical use of biosimilars in patient care, covering biosimilarity assessments, approval pathways, and patient education.
Download Patient Care Case Study
Interchangeable Biosimilars
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.
This case study explores the concept of interchangeable biosimilars, pharmacy-level substitution, and their approval requirements.
Download Interchangeable Case Study
Comparative Analytical Assessment (CAA)
A pharmacist-in-training gains knowledge about the evaluation of biosimilar products during her clinical rotation.
This case study explores the concept of comparative analytical assessments, the evaluation of quality attributes, and how they demonstrate the similarity of biosimilars to reference products.
The Level 2 discussion questions are designed to assess more in-depth understanding of regulatory and scientific concepts related to biosimilars and interchangeable biosimilars.
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:
- Visit FDA Purple Book Search.
- 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 FDA Purple Book Search.
- 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 FDA Purple Book Search.
- 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 Resources
Learn more about biological products, biosimilars, and interchangeable biosimilars from our additional sources: