Evidence map›Paper›PMID 41618370›Full record

ReviewAdvances in rheumatology (London, England)2026

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.

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 and 12 more

Abstract readConsensus StatementReview
In one paragraph

Review in Advances in rheumatology (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Paulo Chicarone PereiraCentro de DoR, São João da Boa Vista, SP, Brasil.
Michel Alexandre YazbekUniversidade Estadual de Campinas, Campinas, SP, Brasil.
Rafaela Bicalho Viana MacedoHospital da Santa Casa de Belo Horizonte, Belo Horizonte-MG, Brasil.
Fabiana Miranda MouraUniversidade Federal de Minas Gerais, Belo Horizonte, MG, Brasil.
Antonio Luíz BoechatUniversidade Federal do Amazonas, Manaus, AM, Brasil.
Julio Cesar Bertacini de MoraesHospital das clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brasil.
Ricardo Machado XavierUniversidade Federal do Rio Grande do Sul, Porto Alegre, SP, Brasil.
Hellen Mary da Silveira de CarvalhoAutoImune- Unidade de Terapia biológica, Brasilia, DF, Brasil.
Amanda de Miranda MarquesBio-Manguinhos/ Fiocruz, Rio de Janeiro, RJ, Brasil.
Francisco Airton Castro da RochaUniversidade Federal do Ceará, Fortaleza, CE, Brasil.
Fabiana Pompeo de PinaUniversidade Federal de Goiás, Goiania, GO, Brasil.
Carla Gonçalves Schahin SaadUniversidade de São Paulo, São Paulo, SP, Brasil.
Claudia Diniz Lopes MarquesUniversidade Federal de Pernambuco, Recife, PE, Brasil.
Karina Rossi BonfiglioliHospital das clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brasil.
Ana Cristina de Medeiros RibeiroHospital das clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brasil.
José Eduardo MartinezPontifÍcia Universidade Católica de São Paulo, Sorocaba, SP, Brasil.
Licia Maria Henrique da MotaUniversidade de Brasília, Brasilia, DF, Brasil.
Marco Antonio Araújo da Rocha-LouresUniversidade Estadual de Maringá, Maringá, PR, Brasil.
Ivanio Alves PereiraUniversidade do Sul de Santa Catarina, Florianópolis, SC, Brasil.
Claudia Goldenstein SchainbergHospital das clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, SP, Brasil.
Alexandre Ibrahim UehbeNovaClin - terapia assistida em Imunobiológicos, Salvador, BA, Brasil.
Valderilio Feijó AzevedoDepartment of Internal Medicine Edumed, Universidade Federal do Paraná, Rua Pedro Viriato de Souza, 130 - casa 1- Vista Alegre, Curitiba, CEP:80820600, Brasil. valderilio@hotmail.com.ORCID http://orcid.org/0000-0002-2346-388X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

objectiveTo 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.

methodsA 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.

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

conclusionThe 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.

Indexed as

Antirheumatic AgentsBiological ProductsBiosimilar PharmaceuticalsDrug SubstitutionRheumatic DiseasesBrazilHumansRheumatologySocieties, MedicalTherapeutic EquivalencyAntirheumatic AgentsBiological ProductsBiosimilar Pharmaceuticals

Identifiers

PMID41618370
PMCPMC13488687

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.