Biosimilars Basics and Beyond: The Science of Biosimilars

A 1-hour continuing education program for pharmacists, physicians, and nurses

Available until July 6, 2018

Full accreditation information and disclosures are available at: http://amcplearn.org/products/1298/biosimilars-basics-and-beyond-the-science-of-biosimilars-home-study

 

Description

Biosimilars have the potential to produce significant health care cost savings in the United States and improve patient access to treatment options. Whether biosimilars are able to fulfill that potential depends in large part on how well they are accepted by payers, clinicians, and patients. The more managed care pharmacy professionals know about how biosimilars are developed, evaluated, approved, and regulated, the more likely they will be to have confidence in the effectiveness and safety of these agents.

This home study program—the first in a two-part series—focuses on the science behind biosimilars and the “totality of the evidence” approach to evaluating biosimilarity. (The second program of this series is titled “Biosimilars Basics and Beyond: Regulating Biosimilars.”)

 

Learning Objectives

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

  1. Define the terms “reference biologic,” “biosimilar,” “interchangeable biosimilar,” and “biobetter.”
  2. Identify key differences between proving generic equivalence to a conventional drug and demonstrating biosimilarity to a reference biologic.
  3. Discuss the foundational role of comparative structural analyses and functional assays in assessing whether a proposed biosimilar is “highly similar” to a reference product.
  4. Explain the importance of pharmacodynamic and pharmacokinetic data in evaluating biosimilars.
  5. State additional requirements for demonstrating that a biosimilar product is interchangeable with a reference product.