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

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4/20/17

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

Thursday, April 20, 2017

Live CME Webinar

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 1-hour live, virtual, evening symposia will be offered in March, April, and September 2017 for physicians and pharmacists who have interest 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.

Through interactive case studies and didactic presentations, physicians and pharmacists will have an opportunity to participate with expert faculty in small-group discussions concerning the eventual introduction of biosimilars in clinical practice.

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

  • Scientific and developmental principles
  • Legislative and regulatory pathways
  • Available efficacy and safety/tolerability data
  • Anticipated biosimilar approvals
  • Considerations for use in clinical practice
  • Approaches to patient education

 

Jointly provided by:

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

Media: Internet

To register for one or more virtual symposia, please click the registration button located at the bottom of the page. You will be directed to the event registration website where more information about each symposium is available.

Curriculum Schedule

Faculty Date / Time Symposia Agenda
John A. Goldman, MD
William F.C. Rigby, MD
Symposium I:
Assessing Clinical Implications of Biosimilars in Rheumatology Practice

Thursday, March 23, 2017
  • 7:00 PM (ET)
  • 6:00 PM (CT)
  • 4:00 PM (PT)

Welcome/Faculty Introductions
(5-minutes)

Setting the Stage: Pre-Activity Knowledge and Demographic Polling
(5-minutes)

Examining the Development & Manufacturing Process of Biosimilars:
Why Biosimilars are not Generic Drugs

(10-minutes)

Requirements for Bringing Biosimilars to Market
(10-minutes)

Case Study: Assessing Clinical Implications of Biosimilars in Practice
(15-minutes)

Faculty / Participant Q&A
(10-minutes)

Key Practice Take-Aways and Post-Session Polling
(5-minutes)

Athos Bousvaros, MD
Russell D. Cohen, MD
Symposium II:
Assessing Clinical Implications of Biosimilars in Adult and Pediatric IBD

April 20, 2017
  • 7:00 PM (ET)
  • 6:00 PM (CT)
  • 4:00 PM (PT)
Russell D. Cohen, MD
John A. Goldman, MD
Symposium III:
Biosimilar Update: Practice Implications in 2017 and Beyond

September 2017
  • 7:00 PM (ET)
  • 6:00 PM (CT)
  • 4:00 PM (PT)
Coming soon...

Faculty

Athos Bousvaros, MD, MPH

Associate Chief, Division of Gastroenterology, Hepatology, and Nutrition
Associate Director, Inflammatory Bowel Disease Center
Associate Professor of Pediatrics
Harvard Medical School
Boston, Massachusetts

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
Emory St. Joseph’s Hospital
Atlanta, Georgia

William F.C. Rigby, MD

Professor of Medicine, Microbiology and Immunology
Division of Rheumatology
Vice Chairman, Academic Affairs
Department of Medicine
Dartmouth Medical School
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire

Educational Objectives

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

  • Explain the scientific and developmental principles in support of biosimilars
  • Evaluate the regulatory requirements for the introduction of biosimilars in the United States
  • Review and assess how extrapolation of indications varies between the reference drug and a biosimilar product
  • 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.

Credit Available

  • Physicians — maximum of 3.0 AMA PRA Category 1 Credits
  • Pharmacists3.0 contact hours (3.0 CEUs)

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

Physician Continuing Medical Education

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 I: Assessing Clinical Implications of Biosimilars in Rheumatology Practice
Live activity; 1.0 AMA PRA Category 1 Credit

Symposium II: Assessing Clinical Implications of Biosimilars in Adult and Pediatric IBD
Live activity; 1.0 AMA PRA Category 1 Credit

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

Pharmacist Continuing Education

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

Symposium I: Assessing Clinical Implications of Biosimilars in Rheumatology Practice.
This session provides 1.0 contact hours (0.1 CEUs) of continuing education credit.
ACPE Universal Activity Number 0297-9999-16-017-L01-P. Type of Activity: Application.

Symposium II: Assessing Clinical Implications of Biosimilars in Adult and Pediatric IBD.
This session provides 1.0 contact hours (1.0 CEUs) of continuing education credit.
ACPE Universal Activity Number 0297-9999-16-018-L01-P. Type of Activity: Application.

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. Type of Activity: Application.

Disclosures of Conflicts of Interest

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:

Athos Bousvaros, MD, MPH
  • Consultant for Clinical Trial Design: Shire; Takeda
  • Grant Research: AbbVie; Janssen Pharmaceutica; Prometheus Laboratories
  • Honorarium: Alexion Pharmaceuticals
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
William F.C. Rigby, MD
  • Consultant/Advisory Board: Scientific information and/or clinical trial design: BMS; Lilly; Pfizer
  • Grant Research: AbbVie; Amgen; BMS; Pfizer

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 curriculum may contain discussion of investigational drugs or off-label uses of approved agents. Faculty will identify these as they occur.

This activity is designed for use by health care professionals for educational purposes only. The opinions expressed in this educational activity are those of the faculty, and do not represent those of the Academy or peerXchange. This activity 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.

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+

Privacy

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

Copyright

© 2017. This CME/CPE-certified activity 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).