This activity provides patient and practice-specific biosimilars content for clinicians in rheumatology practice.
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
This activity is provided by The France Foundation.
This activity is intended for rheumatologists.
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.
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
John R. Tesser, MD
Adjunct Assistant Professor
Division of Clinical Education
Midwestern University, Arizona College of Osteopathic Medicine
Arizona Arthritis & Rheumatology Associates
Theodore Bruno, MD
Chief Medical Officer
The France Foundation
Old Lyme, Connecticut
Cassandra M. Calabrese, DO
Fellow – Rheumatology and Infectious Disease
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.
This activity is supported by an educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.
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.
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Sergio Fazio, MD, PhDPeer