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Background <p>The increasing availability of biosimilars has raised important questions regarding their interchangeability with originator biologics in the treatment of immune-mediated rheumatic diseases. Addressing this issue is critical to ensuring patient safety, therapeutic efficacy, and informed clinical decision-making.</p> Objective <p>To present a position statement from the Biotechnology Committee of the Brazilian Society of Rheumatology on the interchangeability between originator and biosimilar biologic drugs in rheumatologic care.</p> Methods <p>A task force of 22 rheumatologists with expertise in immunobiological therapies followed a structured three-phase consensus process: (1) development of five key questions on biosimilar interchangeability; (2) comprehensive literature review using MEDLINE, EMBASE, and LILACS databases; and (3) final review and endorsement by relevant BSR committees. Expert opinion was used when evidence was limited or inconclusive.</p> Results <p>The position statement comprises five consensus-based recommendations, all unanimously supported by the task force, and supported by current scientific evidence and clinical experience.</p> Conclusion <p>The Biotechnology Committee of the Brazilian Society of Rheumatology endorses the safe and effective interchangeability of originator and biosimilar biologics when guided by principles that ensure patient safety, therapeutic continuity, and healthcare system sustainability.</p> Clinical trial number <p>Not applicable.</p>

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Position statement of the Biotechnology Committee of the Brazilian Society of Rheumatology on the interchangeability of originator and biosimilar biologics in immune-mediated rheumatic diseases

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月30日

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  • Paulo Chicarone Pereira,
  • Michel Alexandre Yazbek,
  • Rafaela Bicalho Viana Macedo,
  • Fabiana Miranda Moura,
  • Antonio Luíz Boechat,
  • Julio Cesar Bertacini de Moraes,
  • Ricardo Machado Xavier,
  • Hellen Mary da Silveira de Carvalho,
  • Amanda de Miranda Marques,
  • Francisco Airton Castro da Rocha,
  • Fabiana Pompeo de Pina,
  • Carla Gonçalves Schahin Saad,
  • Claudia Diniz Lopes Marques,
  • Karina Rossi Bonfiglioli,
  • Ana Cristina de Medeiros Ribeiro,
  • José Eduardo Martinez,
  • Licia Maria Henrique da Mota,
  • Marco Antonio Araújo da Rocha-Loures,
  • Ivanio Alves Pereira,
  • Claudia Goldenstein Schainberg,
  • Alexandre Ibrahim Uehbe,
  • Valderilio Feijó Azevedo

摘要

Background

The increasing availability of biosimilars has raised important questions regarding their interchangeability with originator biologics in the treatment of immune-mediated rheumatic diseases. Addressing this issue is critical to ensuring patient safety, therapeutic efficacy, and informed clinical decision-making.

Objective

To present a position statement from the Biotechnology Committee of the Brazilian Society of Rheumatology on the interchangeability between originator and biosimilar biologic drugs in rheumatologic care.

Methods

A task force of 22 rheumatologists with expertise in immunobiological therapies followed a structured three-phase consensus process: (1) development of five key questions on biosimilar interchangeability; (2) comprehensive literature review using MEDLINE, EMBASE, and LILACS databases; and (3) final review and endorsement by relevant BSR committees. Expert opinion was used when evidence was limited or inconclusive.

Results

The position statement comprises five consensus-based recommendations, all unanimously supported by the task force, and supported by current scientific evidence and clinical experience.

Conclusion

The Biotechnology Committee of the Brazilian Society of Rheumatology endorses the safe and effective interchangeability of originator and biosimilar biologics when guided by principles that ensure patient safety, therapeutic continuity, and healthcare system sustainability.

Clinical trial number

Not applicable.