Switching Between Biologics and Biosimilars in Inflammatory Bowel Disease

Published:September 06, 2018DOI:
      Nearly 20 years ago, biologic therapy was introduced for the treatment of Crohn’s disease (CD) and has since revolutionized the treatment of inflammatory bowel disease (IBD). The first biologic therapy approved by the Food and Drug Administration (FDA) for the treatment of CD was infliximab (Remicade, Janssen Pharmaceuticals). Since its approval in 1998, other biologics have become available for the treatment of IBD, including other anti–tumor necrosis factors (adalimumab, certolizumab pegol, golimumab), anti-integrins (natalizumab, vedolizumab), and anti-interleukin-12/23 therapies (ustekinumab). However, biologic therapy is costly and one of the largest contributors to direct medical costs in IBD. The biosimilars have been introduced in hopes of lowering the cost of biologic therapy through increased competition and treatment options. As the initial biologic therapies near the end of their patents, biosimilars are emerging and are becoming increasingly common for the treatment of IBD, particularly in Europe. There has been great skepticism about the safety and efficacy of biosimilars and as demonstrated in a recent study, many gastroenterologists are not informed about biosimilars and their approval process.
      • Cohen H.
      • Beydoun D.
      • Chien D.
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      Awareness, knowledge, and perceptions of biosimilars among specialty physicians.
      There is a need to disseminate information about biosimilars and their approval process to increase the comfort levels of gastroenterologists as these become a larger part of our practice. Here, we provide an overview of biosimilars, their manufacturing process, the FDA approval process, and the data available describing their safety and efficacy.

      Abbreviations used in this paper:

      BPCI (Biologics Price Competition and Innovation Act of 2009), CD (Crohn’s disease), FDA (Food and Drug Administration), IBD (inflammatory bowel disease), PD (pharmacodynamics), PHSA (Public Health Service Act), PK (pharmacokinetics), UC (ulcerative colitis)
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        Clinical Gastroenterology and HepatologyVol. 18Issue 3
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          Raffals LE, Nguyen GC, Rubin DT. Switching between biologics and biosimilars in inflammatory bowel disease. Clin Gastroenterol Hepatol 2019;17:818–823.
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