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

An on-demand video activity for prescribers seeking to increase their knowledge of biosimilar products.

  • Contact hours: 1.0 (0.10 CEU)
  • Registration is free of charge

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
  1. Explain the characteristics of biosimilars and differences between biosimilars and generic drugs.
  2. Describe the regulations and requirements for the approval of biosimilars.
  3. Review utilization of biosimilars in real world practice using infliximab as an example.
Activity Presenter
Tzu-Yin Kuo, PharmD Fellow
Center for Health Outcomes, Pharmacoinformatics and Epidemiology
University at Buffalo School of Pharmacy and Pharmaceutical Sciences
Intended Audience

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

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).

Accreditation and Certification Information

For physicians/providers:

Accreditation: The University at Buffalo Jacobs School of Medicine and Biomedical Sciences is accredited by 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, register and 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 70% or better.
Initial release date: 6/15/2023
Expiration date: 6/14/2026
Educational Content
Educational Presentation (PDF); to view the video, please register below
Supplementary Material (PDF)