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

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

doi:10.1186/s42358-026-00523-5

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POSITION STATEMENT • Adv. rheumatol. 66 • 2026 • https://doi.org/10.1186/s42358-026-00523-5 linkcopy

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

Authorship SCIMAGO INSTITUTIONS RANKINGS

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.

Question Number	Question
1	Who is the ideal patient to switch from the originator to the biosimilar?
2	What is the minimum period the patient should remain on the same immunobiological before a new switch?
3	Under what circumstances is a reverse switch (return to the originator) justified?
4	Can attending physicians oppose a switch or recommend a return to the originator biologic or another biosimilar?
5	What is the importance of pharmacovigilance and medical education in the context of interchangeability?

Recommendation	Description
1. Ideal Candidates for Switching	Ideal candidates are patients with inactive or low disease activity, with effective and well-tolerated treatment with the originator, or those initiating therapy with an equivalent biosimilar.
2. Avoiding Multiple Switches	Multiple switches (between originator and biosimilars or among biosimilars) should be avoided within less than one year.
3. Reverse Switching	A reverse switch to the originator should be considered only in exceptional cases of confirmed adverse events or proven loss of efficacy, excluding nocebo effects.
4. Prescriber Awareness	Attending physicians may oppose a switch or recommend a return to a previous biologic when clinically justified, based on individual patient factors such as disease activity, prior therapeutic failure, or safety concerns.
5. Pharmacovigilance and Medical Education	Pharmacovigilance and structured medical education are essential pillars for the safe and effective implementation of biosimilar interchangeability in clinical practice. These elements not only ensure alignment with regulatory standards but also play a critical role in safeguarding patient safety, maintaining therapeutic continuity, and fostering public and professional confidence in the adoption of biosimilars.

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Sociedade Brasileira de Reumatologia Av. Brigadeiro Luís Antônio, 2466, Jardim Paulista, 01402-000 - São Paulo, SP, Tel.: +551132897165 - São Paulo - SP - Brazil
E-mail: rbreumatol@terra.com.br

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