Comparative Study of Ferritin Levels between Two Generic Formulations of Deferasirox in Sri Lankan Patients with Beta-Thalassemia Major.

Generic deferasirox (DFX) formulations are increasingly used in resource-limited settings, but evidence of therapeutic equivalence remains limited. A study was designed to compare ferritin trends before and after the introduction of a new generic dispersible deferasirox formulation (2019) that replaced the previous dispersible generic deferasirox preparation among Sri Lankan patients with β-thalassemia major, and to evaluate compliance and adverse effects. A retrospective cohort study was conducted at the North Colombo Teaching Hospital, Sri Lanka, using patients aged 2 years and above with ferritin data before and after 2019. Patients were categorized into monotherapy and combination with desferrioxamine therapy (DFO+DFX) groups. Compliance was assessed using validated criteria. Of 213 patients, 89 met the inclusion criteria (30 monotherapy; 59 combination therapy). No significant differences in ferritin trends were observed before and after the 2019 brand switch in the overall cohort or subgroups. Compliance was strongly associated with ferritin levels, with medium and poor compliance associated with significantly higher ferritin levels. The new generic deferasirox formulation appears therapeutically comparable to the prior generic product. Compliance remains the dominant determinant of ferritin control.