Switching to biosimilars: current perspectives in immune-mediated inflammatory diseases

Expert Opin Biol Ther. 2019 Oct;19(10):1001-1014. doi: 10.1080/14712598.2019.1610381. Epub 2019 May 6.


Introduction: The expiry of patents for biologics has led to the introduction of biosimilars for the treatment of immune-mediated inflammatory diseases (IMIDs). These treatment alternatives may allow earlier and wider access to appropriate therapy for patients without increasing the economic burden on health-care systems. Prescription of biosimilars to treatment-naïve patients is well accepted; however, additional considerations must be taken into account when switching clinically stable patients from reference products to biosimilars. Area covered: We discuss the current considerations related to switching from reference products to biosimilars from a physician and patient perspective. We review the clinical data and real-life experience on switching patients with IMIDs, present the position of the relevant medical societies, and discuss the importance of patient-physician communication and need for shared decision-making. Expert opinion: The introduction of biosimilars provides an opportunity to expand access to treatment for patients with IMIDs across Europe and support the financial sustainability of health-care systems. We anticipate that as the real-world evidence base grows, confirming the results of clinical trials, there will be a corresponding increase in physician and patient acceptance, not only to initiating treatment with a biosimilar, but also to switching medication from a reference product to a biosimilar.

Keywords: Biological therapy; biosimilar; immune-mediated inflammatory disease; switching.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Biosimilar Pharmaceuticals / therapeutic use*
  • Humans
  • Immune System Diseases / drug therapy*
  • Immune System Diseases / genetics
  • Immune System Diseases / immunology
  • Randomized Controlled Trials as Topic


  • Biosimilar Pharmaceuticals