U.S. Food & Drug Administration

Description

This online learning activity will discuss the science of biological products, including size, complexity, and variation. We will describe commonalities between biosimilars and reference biological products and differences in the approval pathways, with an in-depth explanation of the scientific and regulatory concepts for biosimilars and interchangeable biosimilars. In addition, we will discuss the use of these products, including labeling, terminology, and pharmacy substitution. To enhance understanding, we will review case studies to highlight the data that can support biosimilarity and interchangeability. This webinar will also demonstrate the functionality of the Purple Book Database and highlight resources available to health care providers about biosimilars.

References

Biosimilar Curriculum Materials for Health Care Degree Programs: https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars
Purple Book: Database of Licensed Biological Products: https://purplebooksearch.fda.gov/
Welch, J, et al. “The Mannose in the Mirror: A Reflection on the Pharmacokinetic Impact of High Mannose Glycans of Monoclonal Antibodies in Biosimilar Development.” Clin Pharmacol Ther. 2023; May 113(5):1003-1010. doi: 10.1002/cpt.2783 https://pubmed.ncbi.nlm.nih.gov/36322507/
Cohen HP, et al. Switching Reference Medicines to Biosimilars: A Systematic Literature Review of Clinical Outcomes. Drugs. (2018); doi: 10.1007/s40265-018-0881-y
Cohen, H.P., et al. “Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies” BioDrugs. 2022 Sep;38(5):625-637 doi: 10.1007/s40259-022-00546-6. https://pubmed.ncbi.nlm.nih.gov/35881304/
Guidance for Industry: Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products. November 2019. https://www.fda.gov/media/133014/download

Learning Objectives

Review the key definitions, nomenclature, labeling, issues of interchangeability, and similarities and differences between biosimilars and reference biologics.
Describe how biologics differ from small molecules (size, complexity, inherent variation) and compare the biosimilar and generic approval pathways.
Explain the statutory requirements and approval process for biosimilars and interchangeables.
Discuss considerations for prescribing and dispensing biosimilars and interchangeable biosimilars.
Summarize the new resources available for health care providers and faculty to learn more about biosimilar and interchangeable products and how to use the Purple Book Database of Licensed Biological Products.

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.

Continuing Education Accreditation

In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit(s)^™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CPE

This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-074-H01-P, and ACPE Universal Activity Number JA0002895-0000-23-074-H01-T for 1.00 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).

AAPA

FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.00 AAPA Category 1 CME credits. Approval is valid until August 21, 2026. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 1.00 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians, physician assistants, and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

Brahme, Nina, PhD, MPH, Senior Clinical Analyst, Food and Drug Administration - nothing to disclose
Crowley-Ikenberry, Sarah, MA, Senior Communication Advisor, CDER/OND/OTBB - nothing to disclose
Skibinski, Shelley, PharmD, Project Coordinator, FDA/CDER/OND/OTBB - nothing to disclose

Planning Committee

Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.

Registration Information
Registration is complimentary; therefore refunds are not applicable.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
August 23, 2023

Expiration Date
August 21, 2026

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