Biosimilars in the United States: Barriers, Solutions, Real-World Evidence, and the Experience of One Health System

ACPE UAN #:  0233-0000-19-074-H04-P

Release Date:  October 31, 2019

Expiration Date: October 31, 2022

Activity Type: Knowledge-based

Contact Hours: 1.5 

Activity Fee:  Member:  Free              Non-Member:  $30

Target Audience:  Pharmacists who practice in managed care settings.

Activity Description:

As of July 2019, the U.S. Food and Drug Administration (FDA) had approved 25 biosimilar or follow-on biologic products. Of those, only 11 have launched in the U.S. market. The rate of FDA biosimilar approvals has increased in recent years, but uptake has been slow. Lingering barriers to biosimilar utilization in the U.S. include contract negotiations, patent litigation, and uncertainty among patients and prescribers. Decision-makers in the U.S. also need more robust data—particularly reflecting real-world clinical practice—to further break down barriers to biosimilar and follow-on biologic utilization. As U.S. biosimilar uptake gradually increases, the potential for gathering real-world data is robust, including initiatives around multi-source or large- scale observational research. Such data is available through some health systems, which have adopted biosimilars as an essential part of routine care.  This session will provide information on the current landscape of biosimilars in the U.S., barriers to adoption and utilization, real-world approaches to addressing data needs for decision-makers, and the practical experience of a health system where biosimilars are being used. 

Learning Objectives: 

At the completion of this activity, participants should be able to:

  1.  Describe the current approval and marketing status of biosimilars in the United States.
  2.  Recognize lingering barriers to uptake and utilization of biosimilars.
  3.  Explain the role of real-world evidence in supporting biosimilar utilization.
  4.  Discuss the experience of one hospital where biosimilars are being used. 

Schedule of Educational Activity:

This activity consists of an audio recording, pre-test assessment questions (not required to pass to continue), post-test questions (required to pass with a score of 70% or higher) and a specific activity evaluation.


The Academy of Managed Care Pharmacy (AMCP) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

As an accredited provider, AMCP strictly adheres to the ACPE Standards for Commercial Support and other relevant guidelines and standards to ensure the independence of continuing pharmacy education (CPE) activities.  It is AMCP’s intent that all CPE activities be independent, objective, balanced, evidence-based and free of any commercial bias.

CPE Requirements:

Participants should claim continuing pharmacy education (CPE) credit for this home study activity only if they have not claimed credit for the live activity presented at AMCP Nexus 2019.

CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor.  Please allow 72 hours for processing and posting in your NABP account.

To receive credit for an online activity you must:

  • Review the full content of the activity.
  • Successfully complete the post-test (required to pass with a score of 70% or higher, it may be taken a maximum of three times).
  • Complete a specific activity evaluation.


Renee Rizzo Fleming | RPh, MBA | President | PRN Managed Care Consulting Services, LLC | East Amherst, New York.

System Technical Requirements/Viewing Requirements: System Requirements Courses and learning activities are delivered via your Web browser and Acrobat PDF. For all activities, you should have a basic comfort level using a computer and navigating websites.  View the minimum technical and system requirements for continuing education online learning activities.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-19-074-H04-P 1.5 Contact Hours October 31, 2019 - October 31, 2022