FDA offers a variety of materials in multiple formats to help promote understanding of biosimilars and interchangeable products. Explore the available resources FDA has for a variety of audiences, including patients, caregivers, and health care providers.

• Fact Sheets
• Videos
• Infographics

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Fact Sheets

For Health Care Providers  

• Overview of Biosimilar Products (PDF – 2.5 MB)  
  Learn more about biosimilar products.
   
• Biosimilar Regulatory Review and Approval (PDF – 2 MB)
  Learn more about the approval process.
   
• Interchangeable Biological Products (PDF – 1.5 MB)
  Learn more about interchangeable biological products.

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Videos

For Health Care Providers

This video presents the benefits of biosimilars.

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This video provides an overview of biosimilars and the FDA approval process.

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This video explains the interchangeability of biosimilar products and FDA’s rigorous research and evaluation.

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This video outlines FDA’s abbreviated licensure pathway for biosimilars.

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This video describes the data, studies, and analytical tools required to demonstrate biosimilarity.

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Infographics

For Health Care Providers

Biosimilars: Are they the same quality? (PDF 1.5 MB)
This infographic was developed with the United States Pharmacopeia (USP) to help healthcare practitioners explain to patients how biosimilars are high quality products and safe and effective treatment options.

What Is a Biosimilar? (PDF - 220 KB) | (Spanish Version)
This infographic introduces key concepts related to biosimilars, including an introduction to biologics, what “highly similar” means, what “no clinically meaningful differences” means, and how biosimilars are evaluated and monitored.

Biosimilar Development Process (PDF - 382 KB)
This infographic explains the totality of the evidence approach used in determining biosimilarity.

For Patients

Biosimilars Basics infographic (PDF - 388 KB) | (Spanish Version)

Consumer Update

Biosimilar and Interchangeable Biologics: More Treatment Choices
Read the FDA’s Consumer Update to learn more about biosimilars