Embracing Biosimilars in IBD: How Can We Leverage Them in Our Practice?

CME: 1.0

Target Audience

This educational activity is directed toward gastroenterologists, primary care clinicians, nurse practitioners, physician assistants, and other health care professionals involved in the management of inflammatory bowel disease (IBD).

Activity Overview

Biosimilars are biologic products that are highly similar to a previously approved reference (or originator) biologic drugs in terms of safety, purity, and potency (ie, efficacy). Biosimilars first entered United States regulatory pathways following the passage of the Affordable Care Act (ACA), which included the Biologics Price Competition and Innovation Act of 2009. Because biosimilars must be delivered using the same administration route, dose, and frequency as the reference product, they therefore must also be shown to have essentially equivalent pharmacokinetics. Biosimilars may reduce the direct costs of therapy and improve patient access to biologic therapies.

Surveys show that patient and clinician confidence in biosimilars is a major obstacle to their use; however, validated tools are available for guiding discussions that include the Agency for Healthcare Research and Quality (AHRQ) 5-step SHARE approach to shared decision-making. This approach provides structure for the learning that needs to take place with both clinicians and patients to successfully plan treatment that maximizes outcome.

In this program, expert faculty review the approval process for biosimilars and the clinical trial data, including real-world data, regarding their use in patients with inflammatory bowel disease (IBD) and the importance of clear communication between clinicians and patients regarding education on the use of biosimilars to treat IBD.

Learning Objectives

Upon successful completion of this activity, you should be better prepared to:

  • Outline the clinical similarities and differences between a biosimilar and reference biologic product used to manage IBD
  • Describe the regulatory requirements for agents that are approved as biosimilars for reference biologic agents
  • Evaluate clinical trial data and real-world evidence for approved biosimilars compared with reference biologic agents used in the treatment for IBD

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