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Biosimilars in rheumatology.

Filipe César Araújo1, João Gonçalves2, João Eurico Fonseca3

  • 1Rheumatology and Osteoporosis Unit, Hospital de Sant'Ana, Rua de Benguela, 501, 2775-229 Parede, Portugal.

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Summary

Biosimilar medicines offer affordable alternatives for inflammatory rheumatic diseases, improving treatment access and healthcare sustainability. These rigorously regulated biological drugs demonstrate similar clinical performance to reference biologics.

Keywords:
AdalimumabBiosimilarCT-P13EtanerceptExtrapolationInfliximabInterchangeabilityRheumatic diseaseRituximabSB4Switch

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Area of Science:

  • Rheumatology
  • Pharmacoeconomics
  • Biotechnology

Background:

  • Biotechnological therapies are crucial for inflammatory rheumatic diseases (IRD) unresponsive to conventional treatments.
  • These advanced therapies represent a significant economic burden on global healthcare systems.
  • Biosimilars offer a cost-effective solution, potentially enhancing treatment accessibility and system sustainability.

Purpose of the Study:

  • To highlight the importance of biosimilar medicines in managing IRD.
  • To discuss the development, regulatory pathways, and clinical evidence supporting biosimilars.
  • To identify challenges hindering the widespread adoption of biosimilar medicines.

Main Methods:

  • Review of regulatory guidelines for biosimilar development and approval.
  • Analysis of clinical evidence demonstrating the similarity of biosimilars to reference biologics.
  • Examination of economic impact and access considerations for biosimilar adoption.

Main Results:

  • The development of biosimilars for infliximab, etanercept, adalimumab, and rituximab has been facilitated by regulatory frameworks.
  • Regulatory agencies in Europe, North America, and Asia require comprehensive data to confirm biosimilarity.
  • Biosimilars are shown to have highly similar physicochemical, biological, and clinical performances compared to their reference products.

Conclusions:

  • Biosimilar medicines are essential for sustainable healthcare and equitable access to advanced treatments for IRD.
  • Rigorous regulatory oversight ensures the safety and efficacy of biosimilars.
  • Addressing challenges is crucial for maximizing the benefits of biosimilars in clinical practice.