Biologics & Biosimilars: Federal Policies and Patient Access
October 5 | 1-2pm ET
This activity is jointly provided by Global Education Group, the Biologics Prescribers Collaborative and the Institute for Patient Access.
Target Audience: The educational design of this activity addresses the needs of medical doctors and allied health professionals who are interested in the use of biologics and biosimilars to treat patients.
Statement of Need/Program Overview: There is a need for learning activities to educate medical doctors and allied health professionals about the federal approval process, naming and interchangeability of biologics and biosimilars. This activity will help providers improve their knowledge of biologics and biosimilars and be able to help patients overcome barriers when trying to gain access to treatments.
Educational Objectives: After completing this activity, the participant should be better able to:
- Review the U.S. FDA’s approval process for biologics and biosimilars.
- Describe the U.S. FDA’s guidance on naming and interchangeability of biologics.
- Identify the barriers that patients experience when trying to gain access to biologic and biosimilar treatments.
Faculty
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- Dennis Cryer, MD, Co-convener Biologics Prescribers Collaborative
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- Gavin Clingham, JD, Director of Public Policy Alliance for Patient Access
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- David Charles, MD, Founder Alliance for Patient Access Co-convener Biologics Prescribers Collaborative
Agenda
- 1:00-1:05: Welcome & introductions – Dennis Cryer, MD
- 1:05-1:25: Overview of federal policies as they relate to approval, naming and interchangeability – Gavin Clingham, JD
- 1:25-1:45: Presentation of common barriers to patient access with case-based examples – David Charles, MD
- 1:45-2:00: Discussion and audience questions – Dennis Cryer, MD
Physician Accreditation Statement
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Institute for Patient Access. Global is accredited by the ACCME to provide continuing medical education for physicians.
Physician Credit Designation
Global Education Group designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Global Contact Information
For information about the accreditation of this program, please contact Global at 303-395-1782 or [email protected].
Instructions for Obtaining Credit
To receive credit, participants must complete the evaluation. Upon completion, participants will be able to download or email their certificate.
System Requirements
This program will be offered via Zoom. Participants must have the ability to view the presentation and ask questions.
Disclosure of Conflicts of Interest
Global Education Group (Global) adheres to the policies and guidelines, including the Standards for Integrity and Independence in Accredited CE, set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other professional organizations, as applicable, stating those activities where continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous. All persons in a position to control the content of an accredited continuing education program provided by Global are required to disclose all financial relationships with any ineligible company within the past 24 months to Global. All financial relationships reported are identified as relevant and mitigated by Global in accordance with the Standards for Integrity and Independence in Accredited CE in advance of delivery of the activity to learners. The content of this activity was vetted by Global to assure objectivity and that the activity is free of commercial bias.
All relevant financial relationships have been mitigated.
The faculty have the following relevant financial relationships with ineligible companies:
| Name of Faculty or Presenter | Reported Financial Relationship |
| David Charles | Consulting Fee: US World Meds, Revance, Newronika, Ipsen, Merz, Abbott Contracted Research: Merz, Novartis, Pharma2B, Impax, Voyager, Aeon, Supernus Stock Shareholder: Arena Therapeutics |
| Dennis Cryer | Nothing to disclose |
| Gavin Clingham | Nothing to disclose |
The planners and managers have the following relevant financial relationships with ineligible companies:
| Name of Planner or Manager | Reported Financial Relationship |
| Lindsay Borvansky | Nothing to disclose |
| Andrea Funk | Nothing to disclose |
| Liddy Knight | Nothing to disclose |
| Ashley Cann | Nothing to disclose |
| Kim Rodriguez | Nothing to disclose |
| Michelle Winokur | Nothing to disclose |
| David Charles | Consulting Fee: US World Meds, Revance, Newronika, Ipsen, Merz, Abbott Contracted Research: Merz, Novartis, Pharma2B, Impax, Voyager, Aeon, Supernus Stock Shareholder: Arena Therapeutics |
| Dennis Cryer | Nothing to disclose |
| Gavin Clingham | Nothing to disclose |
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. Global Education Group (Global) and Institute for Patient Access do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organization associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Disclaimer
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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