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Background and Importance The European Medicines Agency (EMA) has recently approved elafibranor (ELF) for the treatment of primary biliary cholangitis (PBC) in adults with an inadequate response to ursodeoxycholic acid (UDCA), or as monotherapy in those unable to tolerate UDCA.Aim and Objectives To evaluate whether elafibranor and the main current standard treatments are equivalent therapeutic alternatives (ETA) by performing an indirect treatment comparison (ITC).Material and Methods In August 2025, a literature search was conducted in PubMed using the following criteria: treatment of PBC with ELF, obeticholic acid (OCA), or seladelpar (SEL) in PBC, either in combination with UDCA in patients with an inadequate response, or as monotherapy in those intolerant to UDCA. The comparison variable was biochemical response (BR) at week 52, defined as ALP < 1.67×ULN with ≥15% reduction from baseline and total bilirubin < ULN. Absolute Risk Reduction (ARR) was used for the ITC, applying the Bucher method. The ETA guideline 1 was used to assess therapeutic equivalence. The non-inferiority delta value (∆) was set at ±35%, and the Shakespeare method was used to estimate the probability of exceeding this threshold.Results The comparison included one phase III study for each drug. The results of the clinical trials and the indirect comparison are presented below: OBETICHOLIC ACID (ARR = 37.0 (95% CI 23.7 – 50.3)) SELADELPAR (ARR = 40.9 (95% CI 28.1 – 53.8)) ELAFIBRANOR (ARR = 47.2 (95% CI 36.4 – 57.9)) ARR = 10.2 (-6.9 ; 27,3) p = 0.2424 ARR = 6.3 (-10.45 ; 23.05) p = 0.4611 Both comparisons included the null value and were fully within the equivalence margin. The probability of exceeding the margin was 0.0%.Conclusion and Relevance In accordance with the ETA guideline, ELF can be considered ETA compared to OCA and SEL in terms of BR. OCA is included for reference only, as it is not currently authorised for clinical use. The choice between ELF and SEL should be based on toxicity profile and other response-related variables.References and/or Acknowledgements 1. Alegre Del Rey EJ, et al. Med Clin (Barc) 22 July 2014;143(2):85–90.Conflict of Interest No conflict of interest