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Biosimilar TNF inhibitors demonstrate equivalent efficacy and safety compared to reference products. Real-world data support their use and switching from originator biologics in treating inflammatory diseases.

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Area of Science:

  • Biopharmaceutical development
  • Immunology
  • Rheumatology

Background:

  • Biosimilar regulatory pathways are established globally.
  • Biosimilar TNF inhibitors have been available since 2012 in South Korea and 2013 in the EU.
  • The first biosimilar infliximab launched in the US in 2016.

Purpose of the Study:

  • To review randomized clinical trials (RCTs) on biosimilar efficacy and safety.
  • To assess real-world evidence of biosimilar use and switching.
  • To discuss cost implications and extrapolation of biosimilar indications.

Main Methods:

  • Review of published randomized clinical trials (RCTs).
  • Analysis of real-world data from European Union clinical practice.
  • Evaluation of safety, efficacy, and immunogenicity data.

Main Results:

  • Recent RCTs show equivalent efficacy and comparable safety/immunogenicity of biosimilars to reference products.
  • Growing real-world evidence confirms biosimilar effectiveness and safety in clinical settings.
  • Switching from originator biologics to biosimilars is supported by current data.

Conclusions:

  • Biosimilars offer a cost-effective alternative for treating inflammatory diseases.
  • Extrapolation of biosimilar indications requires careful consideration.
  • Continued monitoring and data collection are essential for biosimilar integration.