Making the Switch: The Use of Biosimilars in IBD Management

Making the Switch: The Use of Biosimilars in IBD Management

On-Demand Webcast
Chair

Raymond K. Cross, MD, MS, AGAF, FACG
University of Maryland School of Medicine
Lutherville, Maryland

Faculty

Marla C. Dubinsky, MD
Icahn School of Medicine at Mount Sinai
New York, New York

Alan C. Moss, MD, FACG
Boston Medical Center
Boston, Massachusetts

Target Audience

This educational activity is designed and certified for the entire IBD healthcare team and includes education for gastroenterologists, pediatric gastroenterologists, surgeons, physicians, PhDs, researchers, pharmacists, nurse practitioners, physician assistants, gastroenterology nurses, and residents/fellows/students.

Overview

Perhaps one of the most important advances in the treatment of inflammatory bowel diseases (IBD) over the last 20 years has been the introduction of biologic agents. The high cost of biologics, however, a consequence of the highly complex production methods required, incurs a substantial burden on the US healthcare system. Biosimilars, medications which are highly similar to the reference biologic with equivalent safety, purity, and potency, can help mitigate these concerns while providing virtually identical treatment results. However, biosimilars are not universally well understood by clinicians, and misplaced apprehensions about their use persist.

In order to effectively incorporate biosimilars into clinical practice, IBD specialists need education on the growing evidence base for these agents showing that they are both safe and effective. Clinicians also need education regarding biosimilar/biologic switching and interchangeability practices and policies, as well as an understanding of the FDA practice of data extrapolation in the approval of biosimilars. Also, patient education is crucial to the successful uptake of biologics into clinical practice, and clinicians must understand the importance of patient education and shared decision making in incorporating biologics into the treatment of IBD. Clinician education is required to overcome these barriers to biosimilar use and make these medications more accessible to patients with IBD.

Objectives

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

  1. Discuss the biosimilar regulatory review process and the characteristics of biosimilars as compared to their originator biologics
  2. Review the most recent safety, efficacy, and switching data for current and emerging biosimilars in IBD
  3. Develop personalized treatment plans that incorporate biosimilars into IBD management where appropriate and include strategies for patient education

Release Date: February 14, 2020

Expiration Date: February 14, 2021

Hardware/Software Requirements

The evaluation is accessible after the activity via a PC (Windows 7 or newer) or Mac (Mac OS 10.6 or later) computer with current versions of the following browsers: Internet Explorer, Mozilla Firefox, Google Chrome, or Safari. A PDF reader is required for print publications. Please direct technical questions to webmaster@naccme.com.

Support

This symposium is supported by educational grants from Merck Sharp & Dohme Corp. and Samsung Bioepis Co., Ltd.

Accreditation

 In support of improving patient care, this activity has been planned and implemented by North American Center for Continuing Medical Education (NACCME) and Imedex. NACCME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team. 

PHYSICIANS

NACCME designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™.

Physicians should claim only the credit commensurate with the extent of their participation in the activity.

PHYSICIAN ASSISTANTS

NACCME has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with the AAPA CME Criteria. This activity is designated for 1.0 AAPA Category 1 credit(s).

PAs should only claim credit commensurate with the extent of their participation.

CNE

This continuing nursing education activity awards 1.0 contact hour.

Provider approved by the California Board of Registered Nursing, Provider #13255 for 1.0 contact hour.

CPE

This knowledge-based activity (JA0006201-9999-20-088-H01-P) is approved for 1.0 contact hour (0.1 CEU) of continuing pharmacy education.

ACPE Credit Policy

Your official record of ACPE credit will be generated through the CPE Monitor System. The certificate printed from this website after completing the evaluation for this activity is for personal tracking purposes only.

Eligibility for pharmacy credit is contingent upon the successful completion of a post-test and/or evaluation for each activity or session attended. Please note that you must complete the activity evaluation within 60 days of a live activity or within 60 days of beginning the evaluation for an enduring activity. Under ACPE Policy, NACCME will not be able to report your activity completion to CPE Monitor after this 60-day period.

Any participant wanting to file a grievance with respect to any aspect of a continuing pharmacy education activity accredited by NACCME may contact the Manager, Accreditation & Compliance, NACCME, in writing at 104 Windsor Center Drive, East Windsor, NJ 08520. The Manager, Accreditation & Compliance will review the grievance and respond within 30 days of receiving the written statement. If the participant is unsatisfied with the response, an appeal to the Senior Director, Accreditation and Compliance, NACCME, may be made for a second level of review.

Planning Committee

The planning committee comprises Raymond K. Cross, MD, MS, AGAF, FACG, Marla C. Dubinsky, MD, Alan C. Moss, MD, FACG; and Chris Bolwell, and Lara Gray, Imedex.

Financial Disclosure and Conflicts of Interest

According to the disclosure policy of NACCME and Imedex, faculty, editors, managers, and other individuals who are in a position to control content are required to disclose any relevant financial relationships with relevant commercial companies related to this activity. All relevant financial relationships that are identified are reviewed for potential conflicts of interest. If a conflict is identified, it is the responsibility of NACCME and Imedex to initiate a mechanism to resolve any conflicts. The existence of these interests or relationships is not viewed as implying bias or decreasing the value of the presentation.

All educational materials are reviewed for fair balance, scientific objectivity of studies reported, and levels of evidence.

Raymond K. Cross, Jr., MD, MS, FACG reports that he is a consultant for AbbVie, Gilead, Lab-Corp, Janssen, Pfizer, and Takeda; and has received grant or research support from AbbVie.

Marla C. Dubinsky, MD reports that she is a consultant for AbbVie, Janssen, Takeda, Pfizer, Celgene, Arena, Genentech, UCB, Salix, Prometheus, Lilly, BMS, Gilead, and Boeringher Ingelheim; has received grant or research support from Pfizer, Prometheus, AbbVie, and Janssen; and is Co-Founder of Mi Test Health and Cornerstones Health.

Alan C. Moss, MD, FACG reports that he is a consultant for Janssen; and has received grant or research support from Pfizer

Chris Bolwell discloses that he holds shares of stock of GlaxoSmithKline.

Lara Gray disclosed no relevant financial relationships with any commercial interests.

UNAPPROVED AND/OR INVESTIGATIONAL USES OF DRUGS AND DEVICES

This activity may contain information about experimental and other uses of drugs or devices that are not currently approved by the European Medicines Agency (EMA) of the European Union or the Food and Drug Administration (FDA) of the United States. Participants are strongly encouraged to consult approved product labeling for any drug or device mentioned in this activity before use. The opinions expressed during this activity are the opinions of the respective authors, presenters or moderators and do not necessarily reflect the opinions of NACCME or Imedex.

Privacy Policy

NACCME and Imedex protect the privacy of personal and other information regarding participants, educational partners, and joint providers. NACCME, Imedex and our joint providers will not release personally identifiable information to a third party without the individual's consent, except such information as is required for reporting purposes to the appropriate accrediting agency.

NACCME and Imedex maintain physical, electronic, and procedural safeguards that comply with federal regulations to guard your nonpublic personal information.

Copyright © 2019 by North American Center for Continuing Medical Education, LLC. All rights reserved. No part of this accredited continuing education activity may be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from North American Center for Continuing Medical Education. The opinions expressed in this educational activity are those of the faculty and are not attributable to NACCME. Clinical judgment must guide each professional in weighing the benefits of treatment against the risk of toxicity. Dosages, indications, and methods of use for products referred to in this activity are not necessarily the same as indicated in the package insert for each product, may reflect the clinical experience of the presenters, and may be derived from the professional literature or other clinical sources. Consult complete prescribing information before administering.