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
Year: 2026
Type: article
Abstract: 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.
Authors: 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
Institutions: Universidade Estadual de Campinas (UNICAMP), Grupo Santa Casa de Belo Horizonte, Universidade Federal de Minas Gerais, Universidade Federal do Amazonas, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Universidade Federal do Rio Grande do Sul, Fundação Oswaldo Cruz, Universidade Federal do Ceará, Universidade Federal de Goiás, Universidade de São Paulo, Universidade Federal de Pernambuco, Pontifícia Universidade Católica de São Paulo, Universidade de Brasília, Universidade Estadual de Maringá, Universidade do Sul de Santa Catarina, Universidade Federal do Paraná
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $2,490
OpenAlex ID: W7126204787