Keeping up with Biosimilars: The Latest on Regulation, Utilization, Monitoring, and Pipeline

ACPE UAN #:  0233-0000-17-038-H04-P

Release Date: March 30, 2017

Expiration Date:  March 30, 2020

Activity Type:    Knowledge-based

Contact Hours:  1.25

Activity Fee:  Member:  $15        Non-Member: $30

Target Audience: Pharmacists who practice in managed care settings.

Activity Overview

Biosimilars continue to hold much interest for managed care professionals, given the implications to health care costs and patient care. With the approval of four biosimilars in the United States and the potential for several more in the coming years, managed care professionals must understand the role of biosimilars in the health care environment. This includes understanding the Food and Drug Administration’s biosimilar approval process, the current regulatory and legislative landscape, and perceived barriers to biosimilar use.  This session will provide a comprehensive update on biosimilars in the United States. In addition to legislative and regulatory news, this program will also provide the latest information on biosimilar products in the pipeline. Integral to all of this is the role of managed care pharmacy to ensure appropriate use. 

Learning Objectives:  

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

1. Summarize the current regulatory and legislative considerations for biosimilars in the United States, and the Food and Drug Administration’s evaluation of evidence supporting the approval of a biosimilar.

2. Discuss the potential efficacy and safety issues associated with biosimilars and the role of managed care pharmacy in utilization of biosimilars.

3. Summarize the current knowledge gaps among health care professionals with regards to biosimilars and resources available to address these gaps.

4. Identify at least three biosimilars that may be approved within the next two years and their potential impact on managed care. 

Schedule of Educational Activity

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

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 the AMCP Annual Meeting 2017.   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.

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 web sites.  View the minimum technical and system requirements for continuing education online learning activities.

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.

Moderator:

Anthony Schueth, MS |  CEO & Managing Partner | Point-of-Care Partners | Coral Springs, Florida 

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-17-038-H04-P 1.25 Contact Hours March 30, 2017 - March 30, 2020