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                Biosimilars

Biosimilars

                        Biosimilar Basics for Patients
          Overview for Health Care Professionals
          Review and Approval
          Biological Product Innovation and Competition
          Biosimilar Product Information
          Biosimilars | Science and Research
          Industry Information and Guidance
          Curriculum Materials for Health Care Degree Programs | Biosimilars
          Multimedia Education Materials | Biosimilars Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Types of Applications
          Therapeutic Biologics Applications (BLA)
          Biosimilars
          Curriculum Materials for Health Care Degree Programs | BiosimilarsBiosimilars Curriculum Materials for Health Care Degree Programs | Biosimilars
  
  	
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              BiosimilarsFDA’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 ResourcesLevel 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 interchangeabilityPresentation 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:

Biological Products, Biosimilars Products, and Interchangeable Biosimilar Products (PDF - 223 KB)
	Generics and Biosimilars (PDF - 250 KB)
	Manufacturing and Variation (PDF - 411 KB)
	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 productsPresentation 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

Manufacturing and Cell Lines

Manufacturing and Cell Lines


Critical Attributes and Variability - Biosimilars

Critical Attributes and Variability


Biosimilar Approval Process

Biosimilar Approval Process


Interchangeability - Biosimilars

Interchangeability


Exercises

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

Navigating the Purple Book
	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.

Understanding Biosimilar Labeling
	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.

Understanding How Biosimilars May be Included in a Formulary
	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**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:

Multimedia Education 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

                                                                                  Content current as of:
      12/13/2022
              
              
Regulated Product(s)
		 DrugsTopic(s)
			  BiosimilarsBiosimilars

          
                        Basics for Patients
          Overview for Health Care Professionals
          Review and Approval
          Biological Product Innovation and Competition
          Biosimilar Product Information
          Science and Research
          Industry Information and Guidance
          Curriculum Materials for Health Care Degree Programs
          Multimedia Education Materials
 
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