Biosimilars - Resources for Professionals

As biosimilars enter the U.S. market, educational resources for professionals and patients are needed to ensure that there is accurate and unbiased information available about biosimilars. The resources provided here are designed to educate medical professionals about biosimilars, including the U.S. Food and Drug Administration (FDA) approval process, interchangeability, perspectives from our European colleagues, and the importance of provider and patient choice in choosing the right medication.

What are Biosimilars?

Biosimilars are biological therapies-- proteins that have been made to target parts of the immune system. Biosimilars are designed to be similar, near identical copies of other already approved biological therapies, also known as the reference product or originator biologic. They are drugs that act just like a reference product, having the same effectiveness and safety in the patient population that it treats. Biosimilars are also taken in the same form as the originator drug (ex. injection or intravenous infusion). The Food and Drug Administration (FDA) has approved biosimilars for the treatment of inflammatory bowel diseases (IBD) like Crohn's disease and ulcerative colitis, which provides more options for you to consider when managing your disease. However, as is the case for all treatments, you should talk to your doctor about potential risks and what options work best for your IBD treatment plan. 

Comprehensive Update of Biosimilar Therapies: Your Questions Answered

Learn how biosimilars are used in the practice of gastroenterology in the US from Comprehensive Update of Biosimilar Therapies: Your Questions Answered - a recorded version of a live webinar held on December 11, 2017. The webcast covers both current evidence on biosimilars for inflammatory bowel diseases and novel approaches to patient education on this topic.

For more information, please click here

This activity is a collaboration of the AGA Institute and the Crohn's and Colitis Foundation. This program is supported by independent educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer.

Talking With Your IBD Patients About Biosimilars

In this on-demand video series, Sophie Balzora, MD, will provide an overview of the concerns patients may have about biosimilar therapies, and how best to address those concerns. Role-play is provided to demonstrate how to have conversations with your patients who may be beginning treatment with biosimilars, or are considering switching to a biosimilar.

For more information, please click here.

This activity is a collaboration of the AGA Institute and the Crohn's and Colitis Foundation. This program is supported by independent educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer.

Consideration in the Use of Biosimilars for Gastrointestinal Disorders

In this on demand webcast, Stephen B. Hanauer, MD, AGAF and David T. Rubin, MD, AGAF provide an overview of the current body of knowledge on the safety and efficacy of biosimilar products.  Biosimilar pricing is explored, as well as the impact of payor decisions on clinical GI practice.  This activity is a collaboration of the AGA Institute and the Crohn's & Colitis Foundation.

At the conclusion of this presentation, learners will:

  • Appreciate the landscape that has contributed to the emergence of biosimilars in the U.S. IBD market 
  • Gain clarity on the definition of biosimilars and the abbreviated FDA approval pathway 
  • Appreciate the rationale for extrapolation of indications 
  • Know that no biosimilar has received an interchangeable designation 
  • Consider the clinical scenarios in which biosimilars may be utilized safely

This program is supported by independent educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer Inc.  

This session is sponsored by the AGA Biosimilars Advisory Panel, Clinical Practice, Immunology, Microbiology & Inflammatory Bowel Diseases, and is a collaboration of the AGA Institute and the Crohn's and Colitis Foundation. 

CME for this program is provided by the AGA Institute. For more information, please Click Here

The Development and Approval of Inflectra, a biosimilar to Remicade: Case Presentation

In this on-demand webinar, Sue Lim, MD, director of the Scientific Review staff with the Therapeutic Biologics and Biosimilars staff at FDA, provides a general review of the requirements for a biosimilar 351(k) application and discusses the approval process for Inflectra. This activity is a collaboration of the AGA Institute and the Crohn's & Colitis Foundation.

This program is supported by independent educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer.

CME for this program is provided by the AGA Institute. For more information, please Click Here


Overview of the Regulatory Framework and FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US

In this on-demand webinar, Sue Lim, MD, director of the Scientific Review staff with the Therapeutic Biologics and Biosimilars staff at FDA, provides an overview of the background, terminology and general requirements for biosimilar and interchangeable product applications. This activity is a collaboration of the AGA Institute and the Crohn's and Colitis Foundation.

This program is supported by independent educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer.

CME for this program is provided by the AGA Institute. For more information, please Click Here


Advent of Biosimilar Products in US GI Practice

Learn how Biosimilars are used in the practice of gastroenterology in the US from this recording of the live session held during DDW 2017 in Chicago (recorded May 9, 2017).  Panelists and presentations include: 

  • Introduction to Biosimilars (15 minutes) - Dr. Gary R. Lichtenstein
  • The US Biosimilars Regulatory Pathway (20 minutes) - Dr. M. Stacey Ricci, M. Eng
  • Clinical Considerations in Use of Biosimilars For Gastrointestinal Disorder (20 minutes) - Dr. Brian G. Feagan
  • Why Patients Should Know About Biosimilars (20 minutes) - Dr. David T. Rubin
  • Panel Discussion (15 minutes)

This program is supported by independent educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Pfizer Inc. 

This session is sponsored by the AGA Biosimilars Advisory Panel, Clinical Practice, Immunology, Microbiology & Inflammatory Bowel Diseases, and is a collaboration of the AGA Institute and the Crohn's and Colitis Foundation. 

CME for this program is provided by the AGA Institute. For more information, please Click Here

Perspectives on Biosimilars

The program below features a moderated discussion on biosimilars and their entry into the US market along with insights from our European Colleagues from ECCO (European Crohn’s & Colitis Organization) . 

Moderator: Dr. Millie Long, University of North Carolina, Chapel Hill, Chair NSAC Professional Education Committee

Panelists: Dr. David Rubin, University of Chicago, Chair NSAC Government & Industry Affairs; Prof. Dr. Silvio, Danese, ECCO President-Elect

Foundation's Biosimilars Position Statement

The Crohn’s & Colitis Foundation advocates on behalf of the 1.6 to 3 million Americans who are affected by Crohn’s disease and ulcerative colitis. The Foundation believes that treatment decisions should be shared between the healthcare provider and the patient. You can find our current biosimilars position statement.

Resources you can share with Patients

Your patients will need to be as informed as possible about biosimilars so that they can work with you to advocate for their healthcare needs. Below are important educational resources you can share with patients.

Other Resources