Monograph: A New Era in the Treatment of Inflammatory Disorders: Understanding the Role of Biosimilars

In 2015, the approval of the first biosimilar by the U.S. Food and Drug Administration (FDA) ushered in a new era of treatment for a range of chronic disorders. Since that time, a large number of biosimilars have been introduced, redefining the landscape of biologic therapy for patients with conditions such as inflammatory diseases. Although biosimilars offer important new treatment options, many clinicians and patients remain reluctant to use these agents due to misperceptions and lack of knowledge regarding the safety and efficacy of such treatment. As has been noted in the literature, a growing body of evidence and increasing “real-world” experience with biosimilars are likely to improve confidence in the use of these agents on the part of both healthcare providers and patients.

Learning Objectives
At the conclusion of this activity, the PA should be better able to:
  • Explain the differences between biosimilars and generics.
  • Describe the process by which biosimilars are approved by the FDA. 
  • Apply knowledge of biosimilars to the use of these agents in patients when initiating treatment or switching from reference biologics for inflammatory conditions.
  • Implement strategies for educating patients regarding biosimilar treatment options as part of shared decision-making.