An Evolving Treatment Landscape for Inflammatory Disease: Debating Interchangeability, Efficacy, and Safety of Biosimilars

Health care spending has grown much faster than the rest of the economy, and this trend is seemingly unsustainable.1 Biologic agents are highly effective against inflammatory diseases, but may be restricted by many health care plans due to cost. Biosimilars offer a potential solution as a cost-effective alternative to biologic agents. Biosimilars have been available in Europe since 2005. In the United States, the first biosimilar monoclonal antibody, infliximab, was approved for rheumatoid arthritis (RA), adult ulcerative colitis (UC), psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and adult and pediatric Crohn’s disease (CD).

A biosimilar is a “biopharmaceutical that is genetically engineered, designed to be highly similar to an existing approved biologic product. Highly similar means that any difference is minor and not considered to be clinically meaningful. Biosimilars are expected to have biologic activity similar to that of existing, approved biopharmaceuticals and comparable efficacy and safety based on a full assessment that includes analytical, preclinical, pharmacokinetics (PK), pharmacodynamics (PD), and clinical studies.”2

In this CME Outfitters Live and On Demand activity, expert faculty will highlight the patient voice while engaging in an evidence-based debate that addresses all aspects of biosimilars including safety, efficacy, and best practices for use.

References:

1. Feagan BG. Debate: biosimilars - use as indicated, in place of our current biologics. Presented at: 2015 Advances in Inflammatory Bowel Diseases: Crohn’s & Colitis Foundation’s Clinical & Research Conference; December 6-9, 2015.
2. Kay J. A primer on biosimilars: how do biosimilars compare with reference biologics and generics? Medscape Website. http://www.medscape.org/viewarticle/837696. Published May 28, 2015.