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