OBJECTIVES: Bemfola, biosimilar follitropin alfa, has been launched in the Italian Market as a treatment for infertility. The aim of this project is to perform a cost-effectiveness evaluation comparing Bemfola to Gonal-f in an Italian contest. METHODS: Starting from “A multi-centre phase 3 study comparing efficacy and safety of Bemfola® versus Gonal-f in women undergoing ovarian stimulation for IVF” by Rettenbacher et al., a cost-effectiveness model was developed to compare costs and efficacies of the two comparators (Bemfola and Gonal-f) in an Italian contest. Clinical data on number of subjects, total dose of gonadotropins, pregnancies and liveborn children, OHSS for both first and second cycle of the study by Rettenbacher et al. were used to feed the model. Costs related to drugs, DRG for ART, specialistic visits and examinations were retrieved from 2015 Italian tariffs. The perspective is the NHS one. Costs of Bemfola and Gonal-f arms were divided by the efficacies, i.e. live birth rate, in order to obtain an average cost per live birth and ICER was also calculated. RESULTS: Gonal-f cost resulted to be €3,550 whereas Bemfola cost resulted to be €3,483. Efficacy, i.e. live birth rate, associated to Gonal-f was 0.52 whereas it was 0.47 for Bemfola. The average cost per live birth was estimated to be €6,787 for Gonal-f and €7,449 for Bemfola. Furthermore, Gonal-f generated an ICER equal to €1,210 compared to Bemfola, which is the additional cost required for Gonal-f to gain an additional live birth in comparison with Bemfola. Gonal-f, although it has a higher acquisition cost in comparison with Bemfola, provides a lower average cost per live birth and an ICER of €1,210. CONCLUSIONS: : The results of this cost-effectiveness analysis indicate that Gonal-f is a cost-efficient treatment strategy for the Italian health service compared to Bemfola in the treatment of infertility.