2018-03-27 15:25:17 UTC

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 and Colitis Foundation.

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

Who Should Take this Course

This activity is intended for gastroenterologists, GI fellows, nurse practitioners, physician assistants and other health care professionals who treat GI disorders.

Learning Objectives

At the conclusion of this presentation, learners will:

  • Explain the general requirements for a biosimilar 351(k) application, and the differences between biosimilar development and standalone development.
  • Describe the biosimilar regulatory approval process as it relates to proposed treatments for IBD.


Please note: The use of brand names throughout this presentation is for illustrative purposes only. AGA does not endorse any product, nor does AGA make any claims regarding the effectiveness of any product. 

Claim CME

CME/Maintenance of Certification (MOC) Information

The AGA Institute is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The AGA Institute designates this enduring activity for a maximum of .75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

In accordance with the ACCME’s Standards for Commercial Support of Continuing Medical Education, all faculty and planning partners must disclose any financial relationship(s) or other relationship(s) held within the past 12 months. The AGA Institute implements a mechanism to identify and resolve all conflicts of interest prior to delivering the educational activity to learners.

Successful completion of this CME activity enables the participant to earn up to .75 MOC points in the American Board of Internal Medicine’s (ABIM) MOC program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC points.

CME/MOC expiration date: April 3, 2019

If you have any questions, please email education@gastro.org

Faculty Relationship and Financial Disclosures

View financial disclosures for presenters, planning committee and staff

Planning Committee

Gary R. Lichtenstein, MD, AGAF, University of Pennsylvania

AGA Staff

Maura H. Davis

Monique S. Dyson, MS, CHES

Alison Kim, PhD

Crohn’s & Colitis Foundation Staff

Orna Ehrlich

Laura Wingate

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