The Value of Biosimilars in IBD

 

Released On
September 26, 2018

Expires On
September 26, 2019

Media Type
Internet

Completion Time
60 minutes

Specialty
Gastroenterology

Topic(s)
Biosimilars in IBD

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This activity is jointly provided by Albert Einstein College of Medicine, Montefiore Medical Center and MCM Education.

 

Supported by an educational grant from Pfizer Inc.

 

Credit Available

  • Physicians — maximum of 1.0 AMA PRA Category 1 Credit(s)

All other health care professionals completing this course will be issued a statement of participation.

Target Audience

This activity is designed to meet the educational needs of gastroenterologists, primary care physicians, NPs, PAs, and other healthcare providers who care for patients with IBD.

Program Overview

A number of biosimilars have been approved in recent years, offering additional treatment options for patients with IBD. Given the novelty of biosimilars in the U.S., it’s not surprising that clinicians have questions. In this activity, faculty will define biosimilars, examine how they’re studied and regulated, and discuss their current and potential role in IBD management, including how they might contribute to value-based care.

Learning Objectives

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

  • Review how biosimilars are similar to and different from their originator biologic.
  • Discuss the biosimilar regulatory review process and similarities in safety and efficacy between biosimilars and originator biologics.
  • Identify biosimilars approved for the treatment of patients with IBD.
  • Describe value-based care and how it differs from fee-for-service care models.
  • Discuss how the use of biosimilars will provide value-based care by improving patients’ health outcomes and quality of care.

Faculty

Russell D. Cohen, MD, FACG, AGAF

Director, Inflammatory Bowel Disease Center
Co-Director, Advanced IBD Fellowship Program
The University of Chicago Medicine
Professor of Medicine
Pritzker School of Medicine
Chicago, IL

Gil Y. Melmed, MD, MS

Co-Director, Clinical Inflammatory Bowel Disease
Cedars-Sinai Medical Center
Professor of Medicine
David Geffen School of Medicine at UCLA
Los Angeles, CA

Sushila Dalal, MD

Inflammatory Bowel Disease Center
The University of Chicago Medicine
Assistant Professor of Medicine
Pritzker School of Medicine
Chicago, IL

CCME Reviewer:

Thomas A. Ullman, MD

Professor of Medicine
Chief, Division of Gastroenterology
Albert Einstein College of Medicine/Montefiore Medical Center
Bronx, NY

Physician Accreditation Statement

This activity has been planned and implemented in accordance with the requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through joint providership of Albert Einstein College of Medicine, Montefiore Medical Center, and MCM Education. Albert Einstein College of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Physician Credit Designation Statement

Albert Einstein College of Medicine designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit(s)™Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosures of Conflicts of Interest

Faculty Disclosures

Russell D. Cohen, MD, FACG, AGAF

  • Speakers bureau: AbbVie, Takeda
  • Consultant: AbbVie, Celgene, Entera Health, Hospira, Janssen, Pfizer Inc., Sandoz, Takeda, UCB
  • Research support: AstraZeneca, Celgene, Gilead Sciences, MedImmune, Mesoblast, Osiris Therapeutics, Pfizer Inc., Receptos, RedHill Biopharma, Sanofi US, UCB

Gil Y. Melmed, MD, MS

  • Consultant: Janssen, Pfizer Inc., Samsung Bioepis
  • Research support: Atlantic Pharmaceuticals, Gilead, Janssen, Pfizer Inc., Takeda

Sushila Dalal, MD

  • Research support: Pfizer Inc., Takeda

Thomas A. Ullman, MD

  • Consultant: Pfizer Inc.

The staff of CCME of Albert Einstein College of Medicine have no disclosures to report with any commercial interests relative to this CME activity.

Kathleen Hines, Vice President, Editorial Services, MCM Education, has no conflicts of interest to disclose.

Disclosure of Unlabeled Use

The Albert Einstein College of Medicine also require that faculty participating in any CME activity and anyone in a position to influence content disclose to the audience when discussing any unlabeled or investigational use of any commercial product, or device, not yet approved for use in the United States.

Contributors whose COIs are irresolvable are not permitted to participate in Einstein CME activities.

Method of Participation

There are no fees to participate in the activity.

  • Click "Start Program"
  • Take the pre-test
  • Review the activity
  • Take the post-test and score 80% (you are allowed a total of 3 attempts)
  • Complete the evaluation
  • View, print, or save a CME certificate verifying your credit/participation in this activity

Course Viewing Requirements

Supported Browsers:
Internet Explorer 8.0+ for Windows 2003, Vista, XP, Windows 7, Windows 8.1 and above
Google Chrome 28.0+ for Windows, Mac OS, or Linux
Mozilla Firefox 23.0+ for Windows, Mac OS, or Linux
Safari 6.0+ for Mac OSX 10.7 and above

Supported Phones & Tablets:
Android 4.0.3 and above
iPhone/iPad with iOS 6.1 or above.

Disclaimer

The opinions expressed in this educational activity are those of the faculty and do not necessarily reflect the opinions or recommendations of their affiliated institutions, the publisher, Albert Einstein College of Medicine & Montefiore Medical Center, Center for Continuing Medical Education, or Pfizer Inc. Any medications, diagnostic procedures, or treatments discussed by the program presenters should not be used by clinicians or other health care professionals without first evaluating their patients’ conditions, considering possible contraindications or risks, reviewing any applicable manufacturer’s product information, and comparing any therapeutic approach with the recommendations of other authorities.

©2018 MCM Education. All rights reserved. None of the contents may be reproduced in any form without prior written permission from the publisher.

RESOURCES

Crohn's and Colitis Foundation
Biosimilars Resources for Professionals

U.S. Food and Drug Administration
Biosimilars
Biosimilar and Interchangeable Products
Biosimilar Development, Review, and Approval
Prescribing Biosimilar and Interchangeable Products
Biosimilar Product Information
Industry Information and Guidance
Webinars, Presentations, and Articles
Patient and Prescriber Outreach Materials

American Medical Association: Steps Forward
Preparing Your Practice for Value Based Care

Articles
Role of Biologics and Biosimilars in Inflammatory Bowel Disease: Current Trends and Future Perspectives
Biosimilars in IBD: From Theory to Practice
Biosimilars in Inflammatory Bowel Disease: A Review of Post-Marketing Experience