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Pinpointing the Top Questions about Biosimilars in Rheumatology

Program Information
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Pinpointing the Top Questions about Biosimilars in Rheumatology
RestartResume
Experts discuss biosimilars and use clinical cases to review utilizing these agents in rheumatology practice.
  • Overview

    This activity provides patient and practice-specific biosimilars content for clinicians in rheumatology practice.

  • Learning Objectives

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

    • Define biosimilars, extrapolation indications, and interchangeability on the basis of FDA definitions and guidance
    • Explain the similarities/differences between biosimilars and originator (reference) biologics, as well as the difference between the terms biosimilar and generic
    • Evaluate key aspects of current FDA guidance that inform the health care provider’s knowledge of the biosimilar approval process, manufacturing, and naming, as well as state regulations surrounding substitution practices
    • Apply foundational knowledge on biosimilars to clinical situations relevant to rheumatology practice 
  • Accredited Provider

    This activity is provided by The France Foundation.

  • Target Audience

    This activity is intended for rheumatologists. 

  • Statement of Need

    Many clinicians are lacking knowledge regarding exactly what biosimilars are, how they are formulated, and how they differ from originator biologic agents. Clinicians also lack clear, accurate, and thorough information regarding the regulatory review and approval process, and related FDA guidance, including the process for/meaning of extrapolated indications and interchangeability designations. Despite the fact that some biosimilar agents are now FDA-approved and many more are expected for review/approval in the near future, practicing rheumatologists are not currently equipped with adequate knowledge regarding specific agents and how to safely and effectively apply them to actual practice, as well as respond to patient questions regarding efficacy and safety concerns.

  • Disclosure Policy

    Faculty

    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
    Orthopaedic & Rheumatologic Institute
    Cleveland Clinic
    Cleveland, Ohio

    John R. Tesser, MD
    Adjunct Assistant Professor
    Division of Clinical Education
    Midwestern University, Arizona College of Osteopathic Medicine
    Glendale, Arizona
    Arizona Arthritis & Rheumatology Associates
    Phoenix, Arizona 

    MOC REVIEWERS

    Theodore Bruno, MD
    Chief Medical Officer
    The France Foundation
    Old Lyme, Connecticut 

    Cassandra M. Calabrese, DO
    Fellow – Rheumatology and Infectious Disease
    Cleveland Clinic
    Cleveland, Ohio 

    Disclosure Policy

    In accordance with the ACCME Standards for Commercial Support, The France Foundation (TFF) require that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. TFF resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs. Furthermore, TFF seeks to verify that all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards of experimental design, data collection, and analysis. TFF is committed to providing learners with high-quality CME/CE activities that promote improvements in health care and not those of a commercial interest.

    Activity Staff Disclosures

    The planners, reviewers, editors, staff, CME committee, or other members at The France Foundation who control content have no relevant financial relationships to disclose.

    Faculty Disclosures-Content Creators/Activity Faculty

    The following faculty report that they have relevant financial relationships to disclose:

    • Leonard H. Calabrese, DO, has served as a consultant for AbbVie, Bristol Myers-Squibb, Centocor Biotech, Genentech, GSK, Horizon, Janssen and Pfizer. He has received honoraria from Crescendo Bioscience.
    • John R. Tesser, MD, has served as a consultant for Amgen, Bristol-Myers Squibb, Crescendo Biosciences/Mallinkrodt, Genentech, Janssen, Lilly, Medac, Pfizer, Sanofi-Genzyme/Regeneron and UCB. He has served on a speaker’s bureau for AbbVie, Amgen, Bristol Myers-Squibb, Crescendo Bioscience, Genentech, Janssen, Lilly, Medac, Pfizer and UCB. He has received research grants or support from AbbVie, Ablynx, Amgen, AstraZeneca, Bristol Myers-Squibb, Boehringer Ingelheim Pharmaceuticals, Inc, Celgene, Genentech, GSK, Janssen, Lilly, Merck KG, Novartis, Pfizer, Sandiz, Sun Pharma, and UCB.

    MOC Reviewer Disclosures

    The faculty listed below report that they have no relevant financial relationships to disclose:

    • Theodore Bruno, MD
    • Cassandra M. Calabrese, DO

    DISCLOSURE OF UNLABELED USE

    TFF requires CME faculty (speakers) to disclose when products or procedures being discussed are off label, unlabeled, experimental, and/or investigational, and any limitations on the information that is presented, such as data that are preliminary, or that represent ongoing research, interim analyses, and/or unsupported opinion. Faculty in this activity may discuss information about pharmaceutical agents that is outside of US Food and Drug Administration approved labeling. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. TFF does not recommend the use of any agent outside of the labeled indications. If you have questions, contact the Medical Affairs Department of the manufacturer for the most recent prescribing information. 

  • Commercial Support Acknowledgment

    This activity is supported by an educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.

  • Disclaimer

    The France Foundation presents this information for educational purposes only. The content is provided solely by faculty who have been selected because of recognized expertise in their field. Participants have the professional responsibility to ensure that products are prescribed and used appropriately on the basis of their own clinical judgment and accepted standards of care. The France Foundation and the commercial supporter(s) assume no liability for the information herein.

    COPYRIGHT INFORMATION
    Copyright © 2017 The France Foundation. Any unauthorized use of any materials on the site may violate copyright, trademark, and other laws. You may view, copy, and download information or software ("Materials") found on the Site subject to the following terms, conditions, and exceptions:

    • The materials are to be used solely for personal, noncommercial, informational and educational purposes. The materials are not to be modified. They are to be distributed in the format provided with the source clearly identified. The copyright information or other proprietary notices may not be removed, changed, or altered.

    • Materials may not be published, uploaded, posted, transmitted (other than as set forth herein), without The France Foundation's prior written permission.

    PRIVACY POLICY
    The France Foundation protects the privacy of personal and other information regarding participants and educational collaborators. The France Foundation will not release personally identifiable information to a third party without the individual's consent, except such information as is required for reporting purposes to the ACCME.

    The France Foundation maintains physical, electronic, and procedural safeguards that comply with federal regulations to protect against the loss, misuse or alteration of information that we have collected from you.

    Additional information regarding The France Foundation’s Privacy Policy can be viewed at http://www.francefoundation.com/privacy.

    CONTACT INFORMATION

    If you have questions about this CME activity, please contact The France Foundation at 860-434-1650 or info@francefoundation.com.

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Programs 11/13/19

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