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New 9‑point guidance drops prognostic stratification, accelerates biological access as biosimilars and generics drive cost convergence
The European Alliance of Associations for Rheumatology (EULAR) has released its 2025 update of the management recommendations for rheumatoid arthritis (RA), consolidating the previous 11 recommendations into a streamlined set of 9.
Published in the Annals of the Rheumatic Diseases [1], the update reflects the growing availability of biosimilar disease‑modifying antirheumatic drugs (bDMARDs) and generic Janus kinase inhibitors (JAKi), which have fundamentally altered the economic calculus of treatment sequencing. This is an update of the previous 2020 recommendations [2] (which contained 12 specific recommendations) and the 2022 recommendations.
Key changes: stratification removed, biologics moved forward
The most consequential change is the elimination of prognostic risk stratification that previously guided whether patients should receive a biological or a further conventional synthetic DMARD (csDMARD) after methotrexate (MTX) failure. The 2022 guidance directed clinicians to assess risk factors—such as autoantibody titres, early erosions, and acute phase reactants—before deciding on the next step. The 2025 task force voted 98% in favour of removing this step, citing evidence that MTX failure itself constitutes an adverse prognostic sign and that additional csDMARD cycling offers limited benefit.
Consequently, the updated algorithm now directs clinicians to add a bDMARD when the treatment target is not achieved with an initial csDMARD strategy, with JAKi remaining an option provided relevant risk factors—including history of major adverse cardiovascular events, malignancy, and thromboembolic events—are evaluated first. The task force voted 81% in favour of keeping the JAKi safety caveats unchanged from 2022, noting that no new randomised controlled trials on cardiovascular or malignancy risk had emerged since the ORAL Surveillance trial.
Overarching principles and recommendations
The update retains five overarching principles, including that treatment must be based on shared decision‑making, that rheumatologists should primarily care for RA patients, and that patients require access to multiple drugs with different modes of action throughout life.
The nine recommendations emphasise:
The biosimilar factor: a driving force behind the shift
While biosimilars are not the headline, they are the enabler of the 2025 update’s most significant strategic change. The task force explicitly cited the ‘availability and recent expansion of the types of bio-similar (bs) DMARDs’ as a reason why ‘economic aspects also become less of an issue in many countries when advancing into phase 2 of the EULAR algorithm’.
The guidance consistently lists bDMARDs—including tumour necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, and sarilumab—and notes that where biosimilars are available (for adalimumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab), they are considered fully interchangeable with their reference products for clinical decision-making, with golimumab biosimilars among the latest to receive approval, in 2026 [3, 4].
Furthermore, the task force noted that generic JAKi are also emerging, further reducing cost barriers. With both biosimilars and generics driving prices downward, the old practice of delaying biological therapy for economic reasons no longer holds the same weight.
Switching and sequencing: practical implications
The recommendations address switching explicitly: if a bDMARD or JAKi fails, treatment with another bDMARD or JAKi should be considered. If one TNF or IL‑6 receptor inhibitor therapy has failed, patients may receive an agent with another mode of action or a second agent from the same class. While there are no randomised controlled trial data on cycling between JAKi, positive observational data exist, and the task force assumes this is a potentially effective approach.
The task force also considered therapeutic drug monitoring (TDM) but concluded it is not required in RA management, as a recent trial showed no benefit over routine care. This simplifies switching decisions: clinicians can base switches on clinical response rather than serum drug levels.
Conclusion
The 2025 EULAR RA recommendations represent the most streamlined guidance to date, reducing the number of recommendations from 11 to 9 and eliminating prognostic stratification. The driving force behind this simplification is the expanding availability of biosimilars and generic JAKi, which have lowered cost barriers and made earlier biologic use economically feasible.
For patients, this means faster access to effective therapies after MTX failure. For healthcare systems, it means more cost‑effective treatment pathways. For biosimilar developers, it confirms that biosimilars are now an integral part of the standard of care in RA, not merely an option for cost‑containment.
As the task force noted, with so many DMARDs available in 2025—including biosimilars—there are ample alternatives for patients who continue to have moderate or high disease activity despite appropriate treatment. The challenge now lies in implementation: ensuring that these streamlined recommendations translate into improved patient outcomes across diverse healthcare settings.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Coherus exits the biosimilars market with sale of Udenyca to Intas Pharmaceuticals [www.gabionline.net].Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 3]. Available from: www.gabionline.net/pharma-news/coherus-exits-the-biosimilars-market-with-sale-of-udenyca-to-intas-pharmaceuticals
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
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