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Biosimilar infliximab: an expert view.

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CT-P13, the first biosimilar monoclonal antibody, demonstrated biosimilarity to its originator. This paper reviews its approval, regulations, and potential use in Italy.

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Area of Science:

  • Biotechnology
  • Immunology
  • Pharmacology

Background:

  • CT-P13 is the first biosimilar monoclonal antibody approved in the EU and Korea.
  • Its large molecular weight necessitates special considerations for biosimilarity assessment compared to smaller molecules.
  • This represents a landmark case for biosimilar monoclonal antibody development.

Purpose of the Study:

  • To summarize global regulations for biosimilar approval.
  • To present the evidence supporting CT-P13's biosimilarity to infliximab.
  • To discuss the expert-driven outlook for CT-P13 in the Italian healthcare system.

Main Methods:

  • Review of current biosimilar regulatory guidelines.
  • Analysis of the analytical, preclinical, and clinical data package for CT-P13.
  • Consensus-building among Italian experts regarding CT-P13's role.

Main Results:

  • CT-P13 successfully met the stringent requirements for biosimilar approval.
  • The comparability exercise for CT-P13 established a precedent for large-molecule biosimilars.
  • Expert opinion suggests a significant potential for CT-P13 in Italy.

Conclusions:

  • CT-P13's approval validates the biosimilar pathway for monoclonal antibodies.
  • The comprehensive data supports its efficacy and safety profile.
  • Its introduction is anticipated to enhance patient access and healthcare economics in Italy.