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.
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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.
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