iQ& RA Biosimilars Intelligence Zone

Program Medium
Internet-based program


Method of Physician Participation Utilized in Learning Process

There are no fees for participating and receiving CME credit for this activity. During the period June 7, 2018 through June 7, 2020, participants must 1) read the learning objectives and faculty disclosures; 2) study the educational activity, and are expected to view all 43 segments, totaling 2.0 hours, to successfully complete the activity and earn CME credit; 3) register and complete the evaluation form and post-test; 4) score 100% on the post-test; and 5) print out CME certificate.

Estimated Time to Complete Educational Activity

2.0 hours. Physicians must study the enduring activity, and are expected to view every segment to successfully complete the activity and earn CME credit.

Course Overview

In this web-based program, physicians will learn how recent developments in basic and clinical research have helped to advance the understanding and application of biosimilar therapies in the management of rheumatoid arthritis..

Release Date

June 7, 2018

Expiration Date

June 7, 2020

Intended Audience
This complimentary CME educational activity is designed for all healthcare providers (HCPs) involved in developing, delivering, consulting, and monitoring care for patients who have rheumatoid arthritis, including rheumatologists, immunologists, internal medicine specialists, and related clinicians.


Registration

Participation in this iQ&A interactive Medical Intelligence Zone is complimentary, and clinicians are invited to view this CME-certified program and/or share this invitation with other colleagues, departmental staff members, and healthcare professionals.

Grantor Support

This activity is supported by an independent medical education grant from Pfizer, Inc.

Accreditation Statement

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the University of Massachusetts Medical School Office of Continuing Medical Education (UMMS-OCME) and CMEducation Resources, LLC. The UMMS-OCME is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation Statement

The University of Massachusetts Medical School designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. 

Policy on Faculty & Provider Disclosure

It is the policy of the University of Massachusetts Medical School to ensure fair balance, independence, objectivity and scientific rigor in all activities. All faculty participating in CME activities sponsored by the University of Massachusetts Medical School are required to present evidence-based data, identify and reference off-label product use and disclose all relevant financial relationships with those supporting the activity or others whose products or services are discussed. Faculty disclosure will be provided in the activity materials.  

Program Faculty and Disclosure

Leonard H. Calabrese, DO
Professor of Medicine
Cleveland Clinic Lerner College of Medicine of Case Western Reserve University
R.J. Fasenmyer Chair of Clinical Immunology
Theodore F. Classen, DO, Chair of Osteopathic Research and Education
Vice Chairman, Department of Rheumatic and Immunologic Diseases
Cleveland, OH

Advisor or consultant for: Bristol-Myers Squibb Company; Genentech, Inc.; UCB Pharma, Inc. Speaker or Speaker’s Bureau: AbbVie Inc.; Bristol-Myers Squibb Company; Crescendo Pharma; GlaxoSmithKline; Genentech, Inc.; Novartis Pharmaceuticals Corporation; Pfizer Inc.; Regeneron Pharmaceuticals, Inc.; UCB Pharma, Inc.
Grant/Research Support: Crescendo Pharma; GlaxoSmithKline; Regeneron Pharmaceuticals, Inc.


Stanley Cohen, MD
Clinical Professor
Department of Internal Medicine
UT Southwestern Medical Center
Co-Director of the Division of Rheumatology
Presbyterian Hospital
Dallas, Texas

Nothing to disclose

Jonathan Kay, MD
Professor of Medicine
Timothy S. and Elaine L. Peterson Chair in Rheumatology
Director of Clinical Research, Rheumatology
University of Massachusetts Medical School
UMass Memorial Medical Center
Rheumatology Center, Memorial Campus
Worcester, MA

Consultant: Amgen Inc; AbbVie Inc; Boehringer Ingelheim Pharmaceuticals, Inc. GmbH; Bristol-Myers Squibb Company; Crescendo Bioscience, Inc; Eli Lilly & Co; Fast Forward Pharmaceuticals, B.V.; Genentech, Inc; GlaxoSmithKline PLC; Janssen Biotech, Inc; Merck Sharp & Dohme Corp.; Novartis Pharmaceuticals Corporation; Pfizer Inc; Samsung Bioepis; Sandoz Inc; Roche Laboratories, Inc.; UCB, Inc
Grant/Research Support: AbbVie, Inc; Ardea Bioscienses, Inc; Eli Lilly and Company; Pfizer Inc; Genentech, Inc; Roche Laboratories, Inc.; UCB, Inc

Joseph Markenson, MD
Department of Rheumatology
Department of Medicine
Hospital for Special Surgery, New York, NY
Attending Physician, Hospital for Special Surgery
Professor of Clinical Medicine, Weill Cornell Medical College
Attending Physician, Department of Medicine, Memorial Sloan-Kettering Cancer Center

Nothing to disclose

Program Managers and Web Editor Disclosure

Program Manager Gideon Bosker, MD has nothing to disclose.

Program Reviewer Denise Leary has nothing to disclose.


Educational Objectives

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

  • Recognize how biosimilars differ from small-molecule generic treatments; and how the approval process, evaluation, clinical trials, manufacturing process, and regulatory features of biosimilars are different from regulatory criteria for small molecule generic compounds
  • Differentiate and make clinical decisions based on primary differences between biosimilar therapies and their reference biologic agents, with a focus on biosimilar, TNF inhibitors in the setting of RA, AS, psoriatic arthritis and related conditions
  • Identify, discuss and understand the clinical and pharmacologic implications of each phase — manufacturing, efficacy and safety testing, PK/PD evaluation, clinical outcomes evaluation — in the stepwise approach to regulatory approval of biosimilar therapies, with a focus on anti-TNF biosimilars available for RA and related disease states
  • Review policy guidance as it relates to biosimilars, including considerations for interchangeability and product naming to ensure and facilitate appropriate, safe, outcome- and cost-effective deployment of anti-TNF biosimilars in the setting of RA, AS, and related rheumatological conditions
  • Evaluate the study design, rationale, results, and clinical implications of the most recent clinical evidence — i.e. clinical trials — focused on the safety and efficacy of approved biosimilar therapies for RA; with a focus on anti-TNF biosimilars in the setting of RA, AS, and related conditions


Hardware and Software Requirements:

To participate in this program, viewers must have a PC or Macintosh computer that has active, ongoing internet access for the duration of the program, as well as a compatible Flash-viewer. An email address is required for registration, and a printer is required to print out the CME certificate.

Privacy Policy

When you participate in a CME activity offered by CMEducation Resources, we ask you for your name, degree, affiliation, street address, telephone number, fax number, and/or e-mail address (the "Information"). We use that Information in the following ways:

  • We use the Information to grade your post-test and to send you a certificate of completion of the CME activity. If we use a third-party company to grade your post-test and issue certificates of completion, we will give the Information to that company for that purpose only.
  • For each CME activity that you take, you must complete an evaluation questionnaire. That questionnaire asks if you are willing to participate in a follow-up survey. If you answer yes, we will use your name and contact information to send you the survey.
  • We may use the Information to send you information about other CME activities that CMEducation Resources is offering.
  • If our company is acquired by or merged into another company, we may make the Information available to the new owner/entity to use in the ways described above, to enable it to continue our business.
  • You should check this privacy policy periodically to see whether we have made any changes.


Disclaimer

Copyright © 2018 by CMEducation Resources, LLC All rights reserved. 

Reproduction, distribution, or translation without express written permission is strictly prohibited. 

Content on this webcast reflects the opinions, output, and analyses of experts, investigators, educators, and clinicians whose activities for, while independent, are commercially supported by the sponsor noted at the start of each activity. 

Content on this webcast is not meant to be, nor substitute for national guidelines or recommendations generated by professional, academic societies, colleges, or associations. 

Content on this webcast is intended for educational value only. Its contents, analyses, and any recommendation made herein are intended to make scientific information and opinion available to health professionals, to stimulate thought, and further investigation. This webcast is not designed nor is any aspect of the contents here intended to provide advice regarding medical diagnosis or treatment for any individual case. Any decisions regarding diagnosis and/or management of any individual patient or group of patients should be made on individual basis after having consulted appropriate sources, whether they be appropriate consultants and/or guidelines and recommendations issued by national organizations, professional societies, governmental health organizations, or similar bodies. This webcast is not intended for use by the layman. 

Opinions expressed herein are not necessarily those of Pharmatecture, LLC, CMEducation Resources, LLC, program supporters or accreditors, but reflect the opinions and analyses of the experts who have authored the material. Mention of products or services does not constitute endorsement. Clinical, legal, financial, and other comments are offered for general guidance only; and professional counsel should be sought for all specific situations.

Copyright © CMEducation Resources, LLC