In early 2026, the Biotechnology Committee of the Brazilian Society of Rheumatology published a position statement on ‘the interchangeability of originator and biosimilar biologicals in immune-mediated rheumatic diseases’ in Advances in Rheumatology. This outlines five key recommendations for physicians.
Biological medicines have transformed treatment for conditions such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. However, their high cost has limited access for many patients. Biosimilars—highly similar versions of already approved biological drugs—have emerged as a strategy to expand access while reducing healthcare expenditure.
Despite their growing availability, questions remain among clinicians about whether patients can safely switch between an originator biological and its biosimilar, or between different biosimilars of the same reference product. This new Brazilian position statement builds on a previous version issued in 2024 [1] and seeks to address these concerns by reviewing current scientific evidence and offering practical guidance for rheumatologists.
To develop the statement, a task force of 22 specialists conducted a comprehensive literature review using the MEDLINE, EMBASE, and LILACS databases. Based on the evidence gathered, they formulated five key recommendations for clinical practice.
The statement notes that, according to evidence from clinical trials, real-world studies, and regulatory evaluations, switching between originator biologicals and biosimilars does not generally compromise safety or effectiveness. Studies involving biologicals such as infliximab and adalimumab have demonstrated comparable clinical outcomes after switching, including similar rates of disease control and adverse events.
The recommendations:
- Physician-led decision making: Any switch between a reference biological and a biosimilar should be decided by the treating physician, based on clinical judgement and individual patient circumstances.
- Patient awareness, communication transparency, and shared decision-making: Patients should be informed when a switch to a biosimilar is planned and should receive clear explanations about biosimilars to minimize concerns and reduce the risk of nocebo effects.
- Avoid automatic pharmacy substitution: Substitution of biologicals without the prescriber’s involvement is discouraged to order to maintain clinical oversight and treatment continuity.
- Maintain pharmacovigilance and traceability: Healthcare systems should ensure clear documentation of the exact biological product used (including brand and batch, when possible) to support safety monitoring and adverse-event tracking.
- Switching is generally safe when monitored: Evidence supports switching from originator biologicals to biosimilars—and, in some cases, between biosimilars—provided patients are clinically monitored and the decision is medically justified.
Beyond clinical practice, the position statement addresses the broader healthcare context in Brazil. Biosimilars have the potential to significantly reduce treatment costs, enabling healthcare systems to treat more patients with advanced biological therapies.
In all cases, the authors stress that biosimilar adoption should be accompanied by robust regulatory oversight, physician engagement, and patient education to ensure that cost-driven policies do not undermine clinical confidence.
The recommendations align with guidance from international regulators and medical organizations, such as the World Health Organization (WHO), the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA); which generally support biosimilar use while emphasizing the importance of maintaining physician involvement in treatment decisions.
Ultimately, the statement concludes that biosimilars represent a safe and effective therapeutic option for immune-mediated rheumatic diseases when used appropriately. The Brazilian rheumatology experts emphasize that interchangeability should be guided by scientific evidence, careful clinical judgment, and transparent communication with patients.
As biosimilar markets continue to expand worldwide, the authors hope the guidance will help clinicians in Brazil navigate treatment decisions while supporting both patient outcomes and healthcare sustainability.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. SBR issues consensus on interchangeability of reference products and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 13]. Available from: www.gabionline.net/biosimilars/general/sbr-issues-consensus-on-interchangeability-of-reference-products-and-biosimilars
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