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Assessing the Role of Biosimilars: What the Future Holds for Clinical Practice

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9/28/17

Assessing the Role of Biosimilars: What the Future Holds for Clinical Practice

Jointly provided by:

This educational activity is supported by independent educational grants from Pfizer and the GI Research Foundation.

Activity Description

Recent and upcoming patent expirations for some of the most commonly used biologic agents in gastroenterology and rheumatology have led to the development of biosimilar products—compounds that are designed to be highly similar to the original, or reference, product, but cannot be identical due to the complexities of producing biologic products. Evidence suggests that clinicians are confused about multiple aspects of biosimilars, including the underlying scientific principles, the development and regulatory pathways, how to use them in clinical practice, and how to educate patients about them.

As a rapidly evolving category of pharmaceuticals, a series of live, virtual, evening symposia were held in March and April 2017 for physicians and pharmacists to engage with experts in the areas of gastroenterology and rheumatology to assess and discuss the latest evidence in support of the anticipated introduction of biosimilars.

The final installment of the biosimilar virtual symposia series will be held on Thursday evening, September 28, 2017, to assess issues pertinent to the introduction and use of bisoimilars in gastroenterology and rheumatology practice. Through co-moderation of the symposium by Russell D. Cohen, MD, FACG, AGAF and John A. Goldman, MD, MACR, FACP, the faculty will examine the current landscape of biosimilars approved in the United States for the treatment of rheumatoid arthritis, Crohn's disease, and ulcerative colitis.

To learn more about the introduction of biosimilars in clinical practice and how they may ultimately impact your practice and delivery of care to your patients, register by clicking the button below in order to hear from experts about

  • Scientific and developmental principles
  • Legislative and regulatory pathways
  • Biosimilar approvals in the United States
  • Considerations for use in clinical practice
  • Approaches to patient education

To register for the virtual symposium, please click the registration button located at the bottom of the page, where you will be directed to the event registration website.

Symposium III

Biosimilar Update: Practice Implications in 2017 and Beyond
Thursday, September 28, 2017 I 7PM (ET) / 6PM (CT) / 4PM (PT)
Faculty: Russell D. Cohen, MD, FACG, AGAF and John A. Goldman, MD, MACR, FACP

Agenda

Welcome/Faculty Introductions
Setting the Stage: Assessment of Biosimilar Knowledge and Competence
Examining the Key Concepts of Biosimilars
Biosimilars Approved in the United States

  • Biosimilars Approved for use in Rheumatology Practice
  • Biosimilars Approved for use in Gastroenterology Practice

Case Studies: Assessing Clinical Implications of Biosimilars in Practice
Faculty / Participant Q&A

Faculty

Russell D. Cohen, MD, FACG, AGAF
Professor of Medicine, Pritzker School of Medicine
Director, Inflammatory Bowel Disease Center
Co-Director, Advanced IBD Fellowship Program
The University of Chicago Medicine
Chicago, Illinois

John A. Goldman, MD, MACR, FACP
Chief, Rheumatology
Clinical Professor of Rheumatology and Immunology Emeritus
Emory St. Joseph's Hospital
Atlanta, Georgia

Educational Objectives

Upon completion of the activities in the curriculum, participants should be better able to:

  • Evaluate the regulatory requirements for the introduction of biosimilars in the United States
  • Contrast analytical, pharmacokinetic, and comparative clinical data between reference and biosimilar products to assess safety, purity, and potency
  • Describe the role of monitoring for efficacy and safety of biosimilars among physicians, pharmacists and patients

Who Should Attend

This curriculum is designed to meet the educational needs of dermatologists, gastroenterologists, internists, family medicine physicians, rheumatologists, pharmacists and other healthcare providers (physicians-in-training; nurse practitioners; physician assistants) involved and/or interested to learn about biosimilars.

Accreditation and Credit Designation

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of American Academy of CME, Inc., and peerXchange. The American Academy of CME, Inc., is accredited by the ACCME to provide continuing medical education for physicians.

The American Academy of CME, Inc. designates each activity for the number of AMA PRA Category 1 Credits™ listed below. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Symposium III: Biosimilar Update: Practice Implications in 2017 and Beyond
Live activity; 1.0 AMA PRA Category 1 Credits

American Academy of CME, Inc. is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

Symposium III: Biosimilar Update: Practice Implications in 2017 and Beyond. This session provides 1.0 contact hours (0.1 CEUs) of continuing education credit. ACPE Universal Activity Number 0297-9999-16-019-L01-P. Application.

Instructions on How to Receive Credit

There are no fees to participate in the live activity. Participants must register in advance, complete the pre-activity survey and participate in the live activity. To receive CME/CPE credit for your participation, please complete the post-test (achieving a passing grade of 70% or greater), and program evaluation. Your certificate will be distributed immediately. For pharmacists, a statement of credit will be issued through the CPE Monitor in 6-8 weeks.

Computer System Requirements

This CME/CPE certified live activity will use a video-based format. Hardware and software requirements necessary to participate during the live event, include:

Windows PC Requirements

  • 1.4GHz Intel® Pentium® 4 or faster processor (or equivalent) for Microsoft® Windows 8 or Windows
  • 8.1 Operating system: Windows 10, 8.1 (32-bit/64-bit), 8.0 (32-bit/64-bit), Windows 7 (32-bit/64-bit)
  • Memory: 1 GB of RAM required, 2 GB recommended
  • Browser: Internet Explorer 9 or later; Windows Edge browser; Mozilla Firefox; Google Chrome
  • Internet connection: DSL, cable modem, or other high-speed connection
  • Flash: Adobe® Flash® Player 13.0+

Macintosh Requirements

  • 1.83GHz Intel Core™ Duo or faster processor
  • Operating system: Mac OS X 10.8, 10.9, 10.10
  • Memory: 1 GB of RAM required, 2 GB recommended
  • Browser: Mozilla Firefox; Apple Safari; Google Chrome
  • Internet connection: DSL, cable modem, or other high-speed connection
  • Flash: Adobe® Flash® Player 13.0+

Disclosure Statement

According to the disclosure policy of the Academy, all faculty, planning committee members, editors, managers and other individuals who are in a position to control content are required to disclose any relevant relationships with any commercial interests related to this activity. 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 and levels of evidence. Disclosures are as follows:

Russell D. Cohen, MD
  • Consultant/Advisory Board: marketing purposes and/or scientific information: AbbVie; Celgene; Entera Health; Hospira; Janssen (Johnson & Johnson/Centocor); Pfizer; Sandoz Biopharmaceuticals; Takeda; UCB Pharma
  • Clinical Trials (PI): AstraZeneca; Celgene; Gilead Sciences; MedImmune; Mesoblast Limited; Osiris Therapeutics; Pfizer; Receptos; RedHill BioPharma; Sanofi-Aventis; UCB Pharma
  • Promotional Speakers’ Bureau: AbbVie; Takeda
John A. Goldman, MD
  • Promotional Speakers’ Bureau: Amgen

Planner and Clinical Peer Reviewer
Mary M. Bridgeman, PharmD, BCPS, CGP, Clinical Associate Professor, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, New Brunswick, NJ: No relevant financial relationships with any commercial interests.

Planning Committee
John JD Juchniewicz, MCIS, CHCP, Paul J. Miniter, MS, and Edward Moylan, RP, American Academy of CME, Inc., and Deborah Dean and Wendy Gloffke, PhD (editorial assistance provided), peerXchange, Inc.: No relevant financial relationships with any commercial interests.

This activity may review brand name reference products and brand name biosimilars in conjunction with the names of biosimilar manufacturers. Faculty will identify these as they occur.

This curriculum is designed for use by health care professionals for educational purposes only. The opinions expressed in this curriculum are those of the faculty, and do not represent those of the Academy or peerXchange. This curriculum is intended as a supplement to existing knowledge, published information, and practice guidelines. Learners should appraise the information presented critically, and draw conclusions only after careful consideration of all available scientific information.

Privacy

For more information about the American Academy of CME privacy policy, please access http://www.academycme.org/privacy.htm

Copyright

© 2017. This CME/CPE-certified curriculum is held as copyrighted © by American Academy of CME, Inc. and peerXchange. Through this notice, the Academy and peerXchange grant permission of its use for educational purposes only. These materials may not be used, in whole or in part, for any commercial purposes without prior permission in writing from the copyright owner(s).

Symposium Registration