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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
FDA Drug Topics: Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers
June 20, 2023
Virtual online via Adobe Connect

Activity Coordinators:
Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov)
Series Description

FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.

Lecture Description
This webinar 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
Series Objectives
  • Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
  • Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
Learning Objectives After completion of this activity, the participant will be able to:
  • 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.
Agenda

Lecture 1 June 20, 2023
Time Topic Speaker
1:00 - 2:00 PM EDT Biosimilars: A Review of Scientific, Regulatory, and Clinical Considerations for Health Care Providers Nina Brahme, PhD, MPH
Shelley Skibinski, PharmD
Sarah Crowley-Ikenberry, MA
Continuing Education Accreditation
Jointly Accredited Provider
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.
ICPE Credit
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 live activity 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 JA0002895-0000-23-012-L99-P, and ACPE Universal Activity Number JA0002895-0000-23-012-L99-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
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. 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
  • Littlefield, Jr, Kenneth P., 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.