Interchangeable Biologics and Biosimilars: The Federal and State Perspective

ACPE UAN #:  0233-0000-16-057-H04-P 

Release Date:  October 5, 2016

Expiration Date:  October 5, 2019

Activity Type:    Knowledge-based

Contact Hours:  1.5

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

Target Audience: Pharmacists who practice in managed care settings.

Activity Overview

To date, nearly half of U.S. states have enacted laws imposing pharmacy notification requirements on the dispensing of interchangeable biologics, but many of these laws have remained silent on the issue of biosimilars. Based on the state and law enacted, the regulatory approval process and adoption of biosimilars may be impacted. As remaining states begin drafting laws or consider the legislative options, understanding what’s happening on the federal level and in other states may be beneficial.

This session will provide an overview of the federal perspective and state laws regarding interchangeable biologics and biosimilars. In addition, the session will discuss the more common trends seen among the states with regards to interchangeable biologics, as well as the outliers, and what the potential impact of these laws may have on pharmacy practice. Using a specific state example, managed care professionals will understand the importance of advocating for effective state laws around these important agents.

Learning Objectives:  

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

  1. Describe the difference between biosimilars and interchangeable biologics.
  2. Summarize the most recent operational issues involving biosimilar adoption including product naming and coding.
  3. Describe the trends on both the federal and with state level related to biosimilars and interchangeability.
  4. Identify the impact of differing laws on the potential adoption of biosimilars.
  5. Discuss how managed care professionals can impact interchangeable biologics and biosimilar laws at the state level.

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 AMCP Nexus 2016.  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.

Paul Lakomski, BS, MBA
Pharmacy Services Manager
Phoenix, New York

Credit Information

Activity Number Credit Amount Accreditation Period
ACPE UAN #0233-0000-16-057-H04-P 1.5 Contact Hours October 05, 2016 - October 05, 2019