The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries

Adv Ther. 2015 Aug;32(8):742-56. doi: 10.1007/s12325-015-0233-1. Epub 2015 Sep 5.


Introduction: Inflammatory autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis) have a considerable impact on patients' quality of life and healthcare budgets. Biosimilar infliximab (Remsima(®)) has been authorized by the European Medicines Agency for the management of inflammatory autoimmune diseases based on a data package demonstrating efficacy, safety, and quality comparable to the reference infliximab product (Remicade(®)). This analysis aims to estimate the 1-year budget impact of the introduction of Remsima in five European countries.

Methods: A budget impact model for the introduction of Remsima in Germany, the UK, Italy, the Netherlands, and Belgium was developed over a 1-year time horizon. Infliximab-naïve and switch patient groups were considered. Only direct drug costs were included. The model used the drug-acquisition cost of Remicade. The list price of Remsima was not known at the time of the analysis, and was assumed to be 10-30% less than that of Remicade. Key variables were tested in the sensitivity analysis.

Results: The annual cost savings resulting from the introduction of Remsima were projected to range from €2.89 million (Belgium, 10% discount) to €33.80 million (Germany, 30% discount). If any such savings made were used to treat additional patients with Remsima, 250 (Belgium, 10% discount) to 2602 (Germany, 30% discount) additional patients could be treated. The cumulative cost savings across the five included countries and the six licensed disease areas were projected to range from €25.79 million (10% discount) to €77.37 million (30% discount). Sensitivity analyses showed the number of patients treated with infliximab to be directly correlated with projected cost savings, with disease prevalence and patient weight having a smaller impact, and incidence the least impact.

Conclusion: The introduction of Remsima could lead to considerable drug cost-related savings across the six licensed disease areas in the five European countries.

Funding: Mundipharma International Ltd.

Keywords: Ankylosing spondylitis; Biosimilar; Crohn’s disease; Infliximab; Psoriasis; Psoriatic arthritis; Remicade®; Remsima®; Rheumatoid arthritis; Ulcerative colitis.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibodies, Monoclonal / economics
  • Antibodies, Monoclonal / therapeutic use
  • Antirheumatic Agents / economics
  • Antirheumatic Agents / therapeutic use
  • Arthritis, Psoriatic* / drug therapy
  • Arthritis, Psoriatic* / economics
  • Arthritis, Rheumatoid* / drug therapy
  • Arthritis, Rheumatoid* / economics
  • Biosimilar Pharmaceuticals / economics
  • Biosimilar Pharmaceuticals / therapeutic use
  • Cost Savings* / methods
  • Cost Savings* / statistics & numerical data
  • Drug Costs / statistics & numerical data*
  • Europe
  • Female
  • Humans
  • Infliximab* / economics
  • Infliximab* / therapeutic use
  • Male
  • Models, Econometric
  • Prescription Fees / statistics & numerical data*
  • Spondylitis, Ankylosing* / drug therapy
  • Spondylitis, Ankylosing* / economics


  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Biosimilar Pharmaceuticals
  • CT-P13
  • Infliximab