Here and Now: Biosimilars for the Treatment of IBD

Here and Now: Biosimilars for the Treatment of IBD

On-Demand Webcast
Chair

David T. Rubin, MD, FACG
University of Chicago Medicine
Chicago, Illinois

Faculty

Suchira Ghosh, JD
Axinn, Veltrop & Harkrider LLP
New York, New York

Stephen B. Hanauer, MD, FACG
Northwestern University
Feinberg School of Medicine
Chicago, Illinois

Target Audience

This educational activity is designed for US-based gastroenterologists and other healthcare professionals (physicians-in-training, nurses, pharmacists, physician assistants, etc) involved and/or interested in the therapeutic management of patients with IBD.

Overview

With the recent approvals of biosimilars for treatment of IBD, healthcare professionals face new challenges when assessing therapeutic options for their patients. In this CME-certified webcast, Steven Hanauer, MD, David Rubin, MD and Suchira Ghosh, JD answer your most frequently asked questions about biosimilars, including: the regulatory approval pathway for biosimilars and how it differs from the reference biologic; the safety-efficacy profiles of currently approved biosimilars in the United States and Europe; and the application of biosimilars in day-to-day clinical practice, utilizing case-based scenarios to explicate key issues. This expert guidance provides a fundamental understanding of the regulatory process of these agents, the biologic rationale for their adoption, and strategies to evaluate their safety and tolerability in clinical practice to enhance patient care.

Objectives

Upon successful completion of this educational activity, participants should be better able to:

  1. Discuss the rationale for use of biosimilars and their potential role in IBD
  2. Identify new and emerging biosimilar agents for the treatment of IBD
  3. Characterize the inherent differences between biosimilars and their reference biologics based on their manufacturing processes
  4. Evaluate the FDA regulatory pathway for approval of biosimilars with that of their reference biologics
  5. Contrast the efficacy and safety/tolerability profiles of IBD biosimilars with those of their reference biologic
Provider

This activity is provided by Imedex®, LLC.
Imedex

Continuing Education

ACCME

Imedex, LLC is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Imedex, LLC designates this internet-based enduring educational activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only credit commensurate with the extent of their participation in the activity.

AAPA accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credits™ from organizations accredited by ACCME or a recognized state medical society. Physician assistants may receive a maximum of 1.0 hour of Category 1 credit for completing this program.

In order to receive credit, participants must successfully complete the post-test and complete the online evaluation form. You will receive an online CME statement of credit to print for your records.

Support

Supported by an educational grant from: Samsung Bioepis.

Disclosure

As a provider accredited by the Accreditation Council for Continuing Medical Education (ACCME), Imedex, LLC must ensure balance, objectivity, independence, and scientific rigor in its educational activities. Faculty are instructed to provide a balanced view of therapeutic options by utilizing generic names to ensure impartiality.

All faculty participating in an Imedex activity are required to disclose relevant financial relationships that may be considered to be related to the subject matter of the educational activity. Disclosure of these commitments and/or relationships is included in these course materials so that participants in the activity may formulate their own judgments in interpreting its content and evaluating its recommendations.

The following indicates the faculty disclosure declaration information and the nature of those commercial relationships.

1=grant/research support 2=consultant 3=speaker’s bureau 4=stock shareholder 5=other support

Stephen B. Hanauer, MD, FACG AbbVie1,2,3; Actavis2; Amgen1,2; Boehringer-Ingelheim2; Bristol Myers Squibb2,5; Celgene1,2; Celltrion2; Ferring2; GlaxoSmithKline1,2; Hospira2; Janssen1,2,3; Lilly1,2; Merck2; Nestle2; Novartis1,2; Novo Nordisk1,2; Pfizer1,2; Prometheus1,2; Receptos1,2; Salix2; Seres Health2; Shire2; Sun Pharmaceuticals2; Takeda1,2,3; Tigenex2; UCB Pharma1,2; VHsquared2
David T. Rubin, MD, FACG AbbVie1,2; American College of Gastroenterology5; Celgene2; Cornerstones Health, Inc.5; Forward Pharma2; Genentech1,2; GoDuRn, LLC5; Janssen Pharmaceuticals1,2; Lockwood Group2; Miraca Life Sciences2; Pfizer2; Prometheus Laboratories1; Roche2; Samsung Bioepis2; Sandoz Pharmaceuticals2; Shire1,2; Takeda1,2; UCB Pharma1,2

The following speakers do not report any affiliation:

Suchira Ghosh, JD  

All materials are included with the permission of the authors.

Imedex, LLC Staff Disclosure of Financial Relationships
All Imedex staff members who are in a position to control content of this activity have no financial relationships with any commercial interests, except for the following individuals:

   Chris Bolwell owns shares of stock of GlaxoSmithKline.

Unapproved Uses

This activity may contain information about experimental and other uses of drugs or devices that are not currently approved by the US Food and Drug Administration (FDA) and/or other national regulatory agencies in the United States and other countries. Participants in the United States are encouraged to consult the FDA-approved product labeling for any drug or device mentioned in this program before use. Participants from other countries should consult with their respective regulatory authorities.

The opinions expressed in this webcast are the opinions of the authors and do not necessarily reflect the opinions of Imedex.

Disclaimer

The material presented and related discussions are not intended to be medical advice, and the presentation or discussion of such material is not intended to create and does not establish a physician-patient relationship. Medical advice of any nature should be sought from an individual’s own physician.

About Imedex

Imedex is a brand and assumed name used by Imedex, LLC (hereby referred to as Imedex). Imedex is solely responsible for this agenda’s content. Although Imedex attempts to ensure that the information in our program is accurate and timely, matters and opinions discussed and/or presented with respect to clinical matters are those of the discussion participants only, and not necessarily those of Imedex. Moreover, although Imedex attempts to identify and integrate the most qualified medical professionals in our program, TO THE FULLEST EXTENT PERMITTED BY LAW, IMEDEX EXPRESSLY DISCLAIM ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OF THIRD PARTIES’ RIGHTS, AND FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE CONTENT PRESENTED. IMEDEX FURTHER MAKES NO REPRESENTATIONS OR WARRANTIES ABOUT THE ACCURACY, RELIABILITY, COMPLETENESS OR TIMELINESS OF THE CONTENT OR ANY MATERIAL PRESENTED.

© 2017 Imedex, LLC. All rights reserved. Reproduction in whole or part is prohibited without prior written consent from Imedex and contributing faculty.

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Release Date: November 30, 2017

Expiration Date: November 30, 2018