A Review of the FDA Approval Pathway for Biosimilars and a Real-World Example of the Use of Infliximab

Activity Description:

Biologic medications are essential for optimal care in many disease states, but these agents have complex structures that prevent the development of conventional, low-cost generic equivalents. The United States Food and Drug Administration (FDA) has created an abbreviated approval pathway for the development of biosimilar drugs, medications highly similar to their reference products, but which can be developed with lower investment of time and resources, without compromising safety and effectiveness.

To increase knowledge of biosimilar products, this video activity reviews the FDA approval pathway for biosimilars, discusses studies required to demonstrate biosimilarity, and introduces studies on the utilization of biosimilars in real-world practice. Potential solutions to overcome barriers to biosimilar adoption are also discussed.

Learning Objectives:

Explain the characteristics of biosimilars and differences between biosimilars and generic drugs.
Describe the regulations and requirements for the approval of biosimilars.
Review utilization of biosimilars in real world practice using infliximab as an example.

Intended Audience: Physicians, physician assistants, nurse practitioners, pharmacists, and other healthcare providers.

Estimated Time to Complete Activity: 60 minutes

Initial Release Date: 6/15/2023

Expiration Date: 6/14/2026

Cost and Registration: There is no fee for this activity. The program is supported by the New York State Department of Health Medicaid Prescriber Education Program (MPEP).

Faculty:

Tzu-Yin Kuo, PharmD Fellow

Center for Health Outcomes, Pharmacoinformatics and Epidemiology

University at Buffalo School of Pharmacy and Pharmaceutical Sciences

Accreditation and Certification Information:

For physicians/providers:

Accreditation: The University at Buffalo Jacobs School of Medicine and Biomedical Sciences is accredited by the ACCME to provide continuing medical education for physicians.

Certification: The University at Buffalo Jacobs School of Medicine and Biomedical Sciences designates this Internet Enduring Activity for a maximum of 1.0 AMA PRA Category 1 Credit (TM). Physicians should claim only the credit commensurate with the extent of their participation in the activity.

For pharmacists:

The University at Buffalo School of Pharmacy and Pharmaceutical Sciences is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This knowledge-based activity has been assigned ACPE # 0044-0000-23-030-H01-P and will award 1.0 contact hour (0.10 CEU) of continuing pharmacy education credit. Credit will be uploaded to the CPE Monitor for those who complete all components of this activity.

Activity Components for Continuing Education Credit:

To obtain continuing education credit, complete the required materials. This continuing education activity contains a pre-test, educational video presentation, supplementary handout, post-test, and program evaluation. Credit will be awarded upon successful completion of the post-test activity, with a score of 80% or better.

Disclosures:

The following planners, presenters and others have either indicated financial relationships with ineligible companies or that no financial relationships exist. An ineligible company is any entity whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. ACCME Standards for Integrity and Independence in Accredited Continuing Education

The following planners/presenters/others do not have any relevant financial relationships with ineligible companies:
Role in Activity	Name
Activity Director, Reviewer	Alexia Sroka, PharmD, BCPS
Reviewer, Planner	Edward M. Bednarczyk, PharmD
Planner, Author, Presenter	Tzu-Yin Kuo, PharmD
Planner	Marsha Nelson
Reviewer	Irene Reilly, PharmD, BCPS
Reviewer	Barbara Rogler, PharmD, MS
Reviewer, Planner	Deborah Targoff, PharmD

Commercial support for this activity (include the name of the ineligible company and nature of the support OR check the box "None")

X None

Software Requirements:

Desktop:

Chrome
Firefox
Safari
Edge
Internet Explorer is NOT supported
Safari 7 and below has known compatibility issues

Mobile:

Smartphones have limited support. Use a desktop or laptop computer for the best experience.
Safari
Chrome

For questions about this activity, please contact: pep@nysdoh.suny.edu

Back to Course Listings Proceed to Course