The Biosimilars Compass: Where Are We Going?

ACPE UAN #:   0233-0000-16-036-H04-P

Release Date:  Friday, April 22, 2016

Expiration Date:   Friday, April 22, 2019

Activity Type:  Knowledge-based  

Contact Hours:   1.25

Activity Fee:  Member:  $15.00             Non-Member:  $30.00


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.   

Target Audience: This repurposed session from the AMCP Annual Meeting 2016 is designed to provide insights and solutions for pharmacists who practice in managed care settings, to help them maintain and enhance their knowledge, skills, and abilities. 

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 one biosimilar 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, opportunities for use of biosimilars, and potential for monitoring of outcomes.

This must-attend session will provide a comprehensive update of where we are in the United States with biosimilars. In addition to the latest legislative and regulatory information, this program will also provide the latest information on biosimilar products in the pipeline and their potential for future use. 

Learning Objectives:  

  1. Summarize the current regulatory and legislative considerations for biosimilars in the United States.
  2. Describe the Food and Drug Administration’s evaluation of evidence supporting the approval of a biosimilar.
  3. Discuss the potential efficacy or safety issues associated with biosimilars and options for ongoing monitoring.
  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 CPE online activity consists of a pre-recorded audio/slide presentation, a pre-test (to establish prior knowledge, not required to pass), a post-test with a score of 70% or higher, and a specific online activity evaluation. 

Faculty Relevant Financial Relationships Disclosure: AMCP asks everyone who is in a position to control the content of a continuing pharmacy education activity to disclose all relevant financial relationships with commercial interests. If AMCP determines that a conflict of interest exists as a result of a financial relationship you have (or that your spouse/partner has), we will need to take appropriate steps to resolve the conflict of interest.

  • Jennifer M. Day, PharmD reports that her spouse is employed by Pfizer Inc.
  • C.Douglas Monroe, RPh,MS reports having no financial relationships with any commercial interests during the past 12 months.
  • AMCP staff report no relevant financial relationships pertinent to this activity: Puneet Singh, PharmD and Ruby Singh, PharmD, BCPS.

Method and CPE Requirements:   

Participants should claim continuing pharmacy education (CPE) credit for this online activity, only if they have not claimed credit for the live activity presented at the AMCP Annual Meeting 2016. 

CPE credit will be processed through the AMCP Learn portal and reported directly to CPE Monitor.  Please allow 24-72 hours for processing and posting in your NABP account.

To receive CPE credit for an AMCP Learn online activity you must:

  • View the entire pre-recorded audio/slide presentation.
  • Successfully complete the post-test with a score of 70% or higher (The post-test will provide feedback.)
  • Complete a specific online 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 the web site.  View the minimum technical and system requirements for online educational activities.

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-16-036-H04-P 1.25 Contact Hours April 22, 2016 - April 22, 2019