Statement of Need
Healthcare 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 healthcare 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 to be approved was filgrastim, a human granulocyte colony-stimulating factor. The first biosimilar to be approved for inflammatory diseases was the monoclonal antibody, infliximab-dyyb. Infliximab-dyyb was approved in April of 2016 for rheumatoid arthritis (RA), adult ulcerative colitis (UC), psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS), and adult and pediatric Crohn’s disease (CD). Since then, 3 additional biosimilars have been approved in the United States and many others are in development.
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 Q & A session, expert faculty go in-depth answering participant questions while offering evidence, guidelines, and quality measures for collaborative strategies to optimally use biosimilars in patients with inflammatory diseases.
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.