Pinpointing the Top Questions about Biosimilars in Dermatology
Provided by The France Foundation.
This activity is supported by an educational grant from Boehringer Ingelheim Pharmaceuticals, Inc.
Scroll to the Bottom of this Information to Begin this Course
Release date: November 30, 2017
Valid through: December 31, 2018
Estimated Time to Complete Activity: 45 minutes
This activity is intended for dermatologists.
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 dermatologists 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.
Upon completion of this activity, participants should be better 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 dermatology practice
- Physicians — maximum of 0.75 AMA PRA Category 1 Credit(s)™
All other healthcare professionals completing this course will be issued a statement of participation.
Steven R. Feldman, MD, PhD
Department of Dermatology
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina
William W. Huang, MD, MPH, FAAD
Residency Program Director
Department of Dermatology
Wake Forest School of Medicine
Winston-Salem, North Carolina
Physician Continuing Medical Education
The France Foundation is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
The France Foundation designates this enduring activity for a maximum of 0.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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.
The following faculty report that they have no relevant financial relationships to disclose:
- William W. Huang, MD, MPH, FAAD
The following faculty report that they have relevant financial relationships to disclose:
- Consultant Fees: Abbvie, Alvotech, Advance Medical, Caremark, Celegene, Galderma Laboratories LP, Gerson Lehrman Group, Guidepoint Global, Janssen, Kikaku, Leo Pharma Inc., Lilly, Merck & Co, Inc., Mylan, Novartis Pharmaceuticals Corporation, Pfizer, Inc., Regeneron, Sanofi, Sienna, Sun Pharma, Suncare Research, Valeant, and Xenoport.
- Grant Support: Abbvie, Celegene, Galderma Laboratories LP, Janssen, Lilly, Novartis Pharmaceuticals Corporation, Pfizer, Inc., Regeneron, Sanofi, and Taro.
- Speaker: Abbvie, Celegene, Janssen, Leo Pharma, Inc., Lilly, Novartis Pharmaceuticals Corporation, Pfizer, Inc., Regeneron, Sanofi, Taro, and Valeant.
- Stockholder: Causa Technologies and Medical Quality Enhancement Corporation.
Method of Participation / How to Receive Credit
Technical Requirements: http://www.francefoundation.com/general-requirements.html
(1) There are no fees for participating in and receiving credit for this activity. (2) Review the activity objectives and CME/CE information. (3) Complete the CME/CE activity. (4) Complete the online posttest. A score of at least 75% is required to successfully complete this activity. The participant may take the test until successfully passed. (5) Complete the CME/CE evaluation/attestation form, which provides each participant with the opportunity to comment on how participating in the activity will affect their professional practice; the quality of the instructional process; the perception of enhanced professional effectiveness; the perception of commercial bias; and his/her views on future educational needs. (6) Credit documentation/reporting: If you are requesting AMA PRA Category 1 Credit(s)™, or a certificate of participation—your CME/CE certificate will be available for download.
Hardware and Software Requirements
This site is best viewed with an HTML5 compatible browser, this list includes the current versions of Microsoft Internet Explorer, Mozilla Firefox, Google Chrome, and Apple's Safari. You can visit the independent (3rd party) site www.whatismybrowser.com to determine if you have the latest version of your browser. Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. That software may be: Adobe Flash, Apple Quicktime, Adobe Acrobat, Microsoft Powerpoint, Windows Media Player, and Real Networks Real One Player. Where such software is required it will be indicated.
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.
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 © 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.
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.
If you have questions about this CME activity, please contact The France Foundation at 860-434-1650 or firstname.lastname@example.org.