Biosimilars Basics and Beyond: Regulating Biosimilars

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

Available until September 20, 2018

Full accreditation information and disclosures are available at:



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 second in a two-part series—focuses on legal and regulatory aspects of biosimilars, with an emphasis on recent FDA guidance documents and developments in patent litigation. (The first program of this series is titled “Biosimilars Basics and Beyond: The Science of Biosimilars.”)


Learning Objectives

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

  1. Discuss how the FDA considers various types of data, including data from comparator products approved outside the United States, in making determination of biosimilarity.
  2. Explain why “indication extrapolation” is considered to be both acceptable and safe.
  3. Outline the FDA framework for designating the nonproprietary name of a biological product.
  4. Identify requirements and recommendations for post-marketing surveillance of biosimilars.
  5. Recognize how the stepwise procedure for resolving potential patent disputes (i.e., the biosimilar “patent dance”) affects the development, approval, and availability of biosimilars.
  6. Review state laws that could affect the use of biosimilars.