A 3D View—Choosing Biosimilars: Substitutability, Safety, and Success
Jonathan Kay, MD
Professor of Medicine and Population & Quantitative Health Sciences
Timothy S. and Elaine L. Peterson Chair in Rheumatology
UMass Memorial Medical Center
University of Massachusetts Medical School
This enduring activity is focused on the implications of biosimilar use in clinical practice.
This activity is designed to meet the educational needs of specialists, internists, nurse practitioners, physician assistants, nurses, pharmacists and other healthcare practitioners who may prescribe biosimilar compounds.
After completing the CME activity, learners should be better able to:
- Differentiate between the terms “biosimilar,” “substitution,” “interchangeable,” and “reference products,” and the difference between the FDA regulatory approval process for biosimilars and for generic medications
- Understand the clinical implications of the manufacturing processes of biosimilars
- Review the level of evidence and research required by the FDA to support the safety and efficacy of biosimilars
- Explain biosimilar application to clinical practice
- Describe biosimilars that have been approved and their current use, efficacy, and safety in GI/Rheumatology
Med Learning Group is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. This CME activity was planned and produced in accordance with the ACCME Essentials.
CREDIT DESIGNATION STATEMENT
Med Learning Group designates this online activity for a maximum of 1.0 AMA Category 1 credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the enduring activity.
NURSING CREDIT INFORMATION
Purpose: This program would be beneficial for nurses who prescribe biosimilar compounds. Credits: 1.0 ANCC Contact Hours.
CNE Accreditation Statement: Ultimate Medical Academy/CCM is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. Awarded 1.0 contact hours of continuing nursing education of RNs and APNs.
DISCLOSURE POLICY STATEMENT
In accordance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, educational programs sponsored by Med Learning Group must demonstrate balance, independence, objectivity, and scientific rigor. All faculty, authors, editors, staff, and planning committee members participating in a MLG‐sponsored activity are required to disclose any relevant financial interest or other relationship with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial services that are discussed in an educational activity.
DISCLOSURE OF CONFLICT OF INTEREST
Jonathan Kay, MD, is a consultant for AbbVie Inc., Boeringher Ingelhim GmbH, Celltrion Healthcare Co., Ltd., Merck Sharp & Dohme Corp, Pfizer Inc., Samsung Bioepis, Sandoz Inc., and UCB, Inc. Dr. Kay receives research grants from Pfizer Inc. and UCBc, Inc., paid to the University of Massachusetts Medical School.
CME Content Review
The content of this activity was independently peer-reviewed. The reviewer of this activity has nothing to disclose.
CNE Content Review
The content of this activity was independently peer reviewed. The reviewer of this activity has nothing to disclose.
The staff, planners, and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity:
Matthew Frese, MBA, General Manager of Med Learning Group, has nothing to disclose.
Christina Gallo, SVP, Educational Development of Med Learning Group, has nothing to disclose.
Diana Tommasi, Director of Medical and Scientific Services, has nothing to disclose.
Ana Maria Albino, Program Manager of Med Learning Group, has nothing to disclose.
Lauren Welch, MA, VP, Accreditation and Outcomes of Med Learning Group, has nothing to disclose.
DISCLOSURE OF UNLABELED USE
Med Learning Group requires that faculty participating in any CME activity 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.
During the course of this lecture, the faculty may mention the use of medications for both FDA-approved and non-approved indications.
METHOD OF PARTICIPATION
There are no fees for participating and receiving CME credit for this online activity. To receive CME/CNE credit participants must:
1. Read the CME/CNE information and faculty disclosures;
2. Participate in the enduring activity; and
3. Complete pre-and-post surveys and evaluation.
You will receive your certificate as a downloadable file.
Med Learning Group makes every effort to develop CME activities that are scientifically based. This activity is designed for educational purposes. Participants have a responsibility to utilize this information to enhance their professional development in an effort to improve patient outcomes. Conclusions drawn by the participants should be derived from careful consideration of all available scientific information. The participant should use his/her clinical judgment, knowledge, experience, and diagnostic decision-making before applying any information, whether provided here or by others, for any professional use.
For CME questions, please contact Med Learning Group at firstname.lastname@example.org
Contact this CME provider at Med Learning Group for privacy and confidentiality policy statement
information at http://medlearninggroup.com/privacy‐policy/
RELEASE DATE: July 31, 2019
EXPIRATION DATE: July 31, 2020
Copyright © 2019 Med Learning Group. All rights reserved. These materials may be used for personal use only. Any rebroadcast, distribution, or reuse of this presentation or any part of it in any form for other than personal use without the express written permission of Med Learning Group is prohibited.