U.S. Food & Drug Administration

Description

This enduring material focuses on reference biologics, biosimilars, and interchangeable biosimilars, and the distinctions between the three classifications. The presenters will discuss how biosimilars can achieve interchangeability status and address concerns that healthcare providers may have when switching their patients between different biosimilar products.

References

Biosimilars: www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars
Safety Outcomes When “Switching” Between Biosimilars and Reference Products: www.fda.gov/drugs/spotlight-cder-science/safety-outcomes-when-switching-between-biosimilars-and-reference-products
Review and Approval: www.fda.gov/drugs/biosimilars/review-and-approval
Overview for Health Care Professionals: www.fda.gov/drugs/biosimilars/overview-health-care-professionals
Interchangeable Biological Products: https://www.fda.gov/media/151094/download?attachment
Purple Book: https://purplebooksearch.fda.gov/

Learning Objectives

Describe the data requirements to support biosimilarity and to determine interchangeability.
Recognize the difference between a reference biologic, a biosimilar, and an interchangeable biosimilar.
Discuss the safety outcomes of switching patients between different biosimilar products.

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

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

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 0.5 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 0.50 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 JA0002895-0000-24-068-H01-P, and ACPE Universal Activity Number JA0002895-0000-24-068-H01-T for 0.50 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 0.50 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 0.50 AAPA Category 1 CME credits. Approval is valid until May 6, 2027. PAs should only claim credit commensurate with the extent of their participation.

CPH

Up to 0.50 CPH Recertification Credits may be earned at this event.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

Roach, Sara, PharmD, Pharmacist, FDA - I have the following relationship(s): Walgreens Pharmacy - Employee
Yim, Sarah, MD, Director, Office of Therapeutic Biologics and Biosimilars - nothing to disclose

Planning Committee

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
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.

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

Initial Release Date
May 7, 2024

Expiration Date
May 6, 2027

The .gov means it's official.

The site is secure.