Optimizing Biological and Biosimilar Therapies in the Modern Era

Optimizing Biological and Biosimilar Therapies in the Modern Era

On-Demand Webcast

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


Raymond K. Cross, Jr., MD, MS
University of Maryland Medical Center
University of Maryland School of Medicine
Baltimore, Maryland

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

Target Audience

This activity is intended for IBD specialists, gastroenterologists, GI fellows, and other healthcare professionals (internists, primary care physicians, nurse practitioners, physician assistants, nurses, pharmacists, etc) involved and/or interested in the therapeutic management of patients with IBD.


Biosimilars, biological products that are nearly identical to a reference medicinal product in terms of safety, purity, and potency, have been approved in the European Union since 2006, and 5 biosimilar products have been approved by the FDA for use in patients with inflammatory bowel disease (IBD) to date. With many more biosimilar versions of biologics used for the management of IBD on the horizon, clinicians are challenged to evaluate the both the rationale for biosimilar use and the potential safety and efficacy considerations related to their use in clinical practice.
This webcast aims to provide expert guidance to help clinicians interpret the issues surrounding the use of biosimilars and prepare them to evaluate clinical data regarding biosimilars in patients with IBD.


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

  1. Describe the regulatory requirements for biosimilars approval such as the clinical data package, totality of evidence, extrapolation of data, interchangeability, and substitution
  2. Evaluate recently approved and late-stage anti-TNF biosimilars and their respective safety, efficacy, biosimilarity, and switching data
  3. Incorporate biosimilars for the treatment of IBD into individualized treatment plans
  4. Initiate strategies to educate and inform patients about biosimilar benefits, limitations, core concepts, and impact on accessibility

Release Date: December 21, 2018

Expiration Date: December 21, 2019

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.


Supported by an educational grant from Samsung Bioepis.


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


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.



Imedex 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.


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.


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.


This knowledge-based activity (JA0006201-9999-18-243-H01-P/JA0006201-9999-19-115-H01-P) is approved for 1.0 contact hours (0.01 CEUs) 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, Jr., MD, MS, Stephen B. Hanauer, MD, FACG, and David T. Rubin, MD, FACG; and Chris Bolwell, Manjusha Sala, Monalisa Singh, and Susan Yarbrough, 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 conflicts of interest 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 the conflict(s). 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. Faculty are instructed to provide a balanced view of therapeutic options by utilizing generic names to ensure impartiality.

All faculty 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

Raymond K. Cross, Jr., MD, MS AbbVie1,2; Janssen2; Pfizer2
Stephen B. Hanauer, MD, FACG AbbVie1,2,3; Actavis2; Allergan1,2; Amgen1,2; Arena2, Boehringer Ingelheim2; Bristol-Myers Squibb2; Celgene1,2; Celltrion2; Ferring2; Genentech1,2; GlaxoSmithKline1,2; Hospira2; Janssen1,2,3; Lilly1,2; Merck2; Nestle2; Novartis1,2; Pfizer1,2; Prometheus1,2; Receptos1,2; Salix2; Samsung Bioepis2; Sanofi-Aventis1,2; Seres Health2; Shire2; Takeda1,2,3; Therakos2; Tigenex2; UCB Pharma1,2; VHsquared2
David T. Rubin, MD, FACG AbbVie1,2; Abvenomics2; Allergan, Inc.2; American College of Gastroenterology5; Amgen2; Celgene Corporation2; Cornerstones Health, Inc.5; Forward Pharma2; Genentech1,2; GoDuRn, LLC5; Janssen Pharmaceuticals1,2; Merck & Co., Inc.2; Miraca Life Sciences2; Mitsubishi Tanabe Pharma Development America, Inc.2; Napo Pharmaceuticals2; Pfizer2; Prometheus Laboratories1; Roche1,2; Salix Pharmaceuticals, Inc.2; Samsung Bioepis2; Sandoz Pharmaceuticals2; Shire1,2; Takeda1,2; Target PharmaSolutions, Inc.2; UCB Pharma1

All materials are included with the permission of the authors.

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

Manjusha Sala, Monalisa Singh and Susan Yarbrough disclosed no relevant financial relationships with any commercial interests.

NACCME and Imedex require faculty to inform participants whenever off-label/unapproved uses of drugs and/or devices are discussed in their presentations.

Disclosure of off-label/unapproved uses of drugs and/or devices will be provided prior to the symposium.

Privacy Policy

NACCME protects the privacy of personal and other information regarding participants, educational partners, and joint sponsors. NACCME and our joint sponsors 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 maintains physical, electronic, and procedural safeguards that comply with federal regulations to guard your nonpublic personal information.

Copyright © 2018 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.