Drugs

Patient and Prescriber Outreach Materials

FDA offers a variety of patient and prescriber outreach materials, including graphics, drop-in content, and social media messages, to help promote understanding of biosimilars and interchangeable products.

Videos

The Promise of Biosimilarsdisclaimer icon

This video presents the benefits of biosimilars, featuring FDA Commissioner Scott Gottlieb, M.D., and Director of OND Therapeutic Biologics and Biosimilars Staff, Leah Christl, Ph.D.

Thumbnail of The Promise of Biosimilars video

The Basics of Biosimilarsdisclaimer icon

This video provides an overview of biosimilars and the FDA approval process, featuring Leah Christl, Ph.D., Director of OND Therapeutic Biologics and Biosimilars Staff at FDA CDER.

Thumbnail of The Basics of Biosimilars video

The Concept of Interchangeabilitydisclaimer icon

This video explains the interchangeability of biosimilar products and FDA’s rigorous research and evaluation, featuring Leah Christl, Ph.D., Director of OND Therapeutic Biologics and Biosimilars Staff at FDA CDER.

Thumbnail of The Concept of Interchangeability video

The Biosimilar Development Processdisclaimer icon

This video outlines FDA’s abbreviated licensure pathway for biosimilars, featuring Sue Lim, M.D., Director of the Scientific Staff, OND Therapeutic Biologics and Biosimilars Staff at FDA CDER.

Thumbnail of The Biosimilar Development Process video

Analytical Data for Biosimilar Productsdisclaimer icon

This video describes the data, studies, and analytical tools required to demonstrate biosimilarity, featuring Steve Kozlowski, M.D., Director of the Office of Biotechnology Products at OPQ, FDA CDER.

Thumbnail of Analytical Data for Biosimilars video
Fact Sheets

Biological Product Definitions (PDF – 230 KB)
Learn more about biologics, biosimilars, interchangeable products, and other related terms.

 

 

Biosimilar Product Regulatory Review and Approval (PDF – 206 KB)
Learn more about the development, review, and approval processes for biologics.

 

 

Prescribing Biosimilar Products (PDF – 187 KB)
Learn more about the prescribing of biosimilar products.

 

 

Prescribing Interchangeable Products (PDF – 166 KB)
Learn more about the prescribing of interchangeable products.

 
Infographics

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

Biosimilar Development Process

What Is a Biosimilar? (PDF - 220 KB)
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.

Stakeholder Toolkit

The following information is provided to help you promote FDA as a resource for information on biosimilars and interchangeable products and encourage prescribers and patients to talk to each other about these medications.

 

An Introduction to Biologics (GIF - 4.5 MB)
A shareable GIF that introduces a few key characteristics of biologics

Introduction to Biosimiliars Thumbnail

The Benefits of Biosimilars (GIF - 5 MB)
A shareable GIF that conveys some of the benefits of biosimilars being introduced in the United States.

Benefits of Biologics Icon

Biosimilar Safety and Monitoring (GIF - 4 MB)
A shareable GIF that reviews why FDA-approved biosimilars are safe and how they are monitored.

Biosimilars Safety and Monitoring Icon

Badges that can be posted on websites and link to the FDA biosimilars webpage.

 

Have questions about biosimilars?
This print ad, which covers key terms, how biosimilars are developed and approved, and the data required to demonstrate biosimilarity, aims to inform prescribers of the resources FDA has available.

FDA Biosimilars Resources (JPEG – 222 KB)
A shareable JPEG that introduces FDA’s biosimilars educational resources.

FDA Biosimilar Resources

 

FDA Approval (JPEG – 200 KB)
A shareable JPEG that shows key factors for the FDA approval of biosimilars.

FDA Approval

 

Safety and Effectiveness (JPEG – 138 KB)
A shareable JPEG that emphasizes that biosimilars are safe and effective.

Safety and Effectiveness

 

Complex Molecules (JPEG – 144 KB)
A shareable JPEG that shows that biosimilars are large and generally complex molecules.

Complex Molecules

 

Data Requirements (JPEG – 107 KB)
A shareable JPEG that shows that biosimilars are large and generally complex molecules.

Data Requirements

 

A #biosimilar is approved by FDA after rigorous and thorough evaluation.
Visit www.fda.gov/biosimilars to learn more.

Curious about #biosimilars? Check out FDA’s new educational materials at www.fda.gov/biosimilars.

Qs about the #biosimilars approval pathway? About prescribing them? Learn more
at www.fda.gov/biosimilars.

Are #biosimilars the same as generic drugs? Download FDA’s fact sheet to learn
more. http://bit.ly/2xZsvb1

Extrapolation is key to the #biosimilars development pathway. Download FDA’s fact sheet to learn
more. http://bit.ly/2gCHu3f

Before your patients ask about #biosimilars, learn more about prescribing them. New fact sheet from
FDA. http://bit.ly/2zwN0YL

It’s not too early to learn more about #interchangeable biological products. New fact sheet from
FDA. http://bit.ly/2zwN0YL

What is a #biosimilar? Download FDA’s #infographic for 4 fast facts about
#biosimilars. http://bit.ly/2ivoV1b

#Biosimilars are safe and effective treatment options for patients. Learn more
at www.fda.gov/biosimilars.

FDA has high standards for #biosimilars. Learn more at www.fda.gov/biosimilars.

Need more information on biosimilars? FDA has launched the biosimilars education campaign. See what materials are currently available and what is coming soon. www.fda.gov/biosimilars

Curious about biosimilars? Explore FDA’s new educational materials. www.fda.gov/biosimilars

Have questions about biosimilars? FDA has released new materials biosimilar definitions, details on the approval pathway, and information about prescribing biosimilar and interchangeable products. www.fda.gov/biosimilars

FDA has approved 7 biosimilar products. What are biosimilars? Read the new Biological Product Definitions fact sheet to learn more. http://bit.ly/2xZsvb1

What is extrapolation, and why is it important to the biosimilar development and approval pathway? Download FDA’s Biosimilar Product Regulatory Review and Approval fact sheet. http://bit.ly/2gCHu3f

What are the differences between receiving a reference product versus a biosimilar? Read FDA’s new fact sheet on prescribing biosimilars for more information. http://bit.ly/2zwN0YL

Want to learn more about biosimilars? Download FDA’s infographic for 4 fast facts. http://bit.ly/2ivoV1b

Why may biosimilars cost less? Market competition drives down price, but not quality, safety, or effectiveness. Learn more at www.fda.gov/biosimilars.

Drop-In Content

Newsletter Articles for Prescribers and Patients
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Page Last Updated: 05/22/2018
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