Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.
Uncertainties expressed by prescribers, patients and decision makers call for the production of clinical practice data that can provide timely and valid answers on these issues.
A recent Italian study published in Drug Safety tries to dispel these doubts by evaluating the effectiveness and safety of such switching in patients with chronic kidney disease (CKD) [1].
The multi-database cohort study was conducted using healthcare databases from four Italian geographical areas. The cohort consisted of CKD patients initiating long-term epoetin alpha therapy (erythropoiesis-stimulating agents [ESA-α]) between 2009 and 2015. Switching was defined as any transition between originator/biosimilar ESA-α to any other epoetin in a series of two consecutive prescriptions up to two years. Switchers were matched 1:1 with non-switchers by baseline propensity score and duration of treatment. Lack of effectiveness and safety of switching versus non-switching were evaluated through Cox regression models. In addition, a direct comparison between the two switcher cohorts, i.e. switchers from originator to any other ESAs or from biosimilars to any other ESAs, was also performed.
The study involved 14,400 users of ESA-α for anaemia due to CKD (61.4% originator, 38.6% biosimilar). The results showed no differences in effectiveness [HR = 1.02; 0.79-1.31 originators; HR = 1.16;0.75-1.79 biosimilars] and safety outcomes [HR = 1.08; 0.77-1.50 originators; HR = 1.20;0.66-2.21 biosimilars] between ESA-α switchers and non-switchers. Cumulative probabilities of recording an adverse event, either in terms of lack of effectiveness or safety issue, were found to be highly similar for both switching groups. The robustness of the results was confirmed by several pre-specified subgroup analyses.
In summary, this large-scale observational study suggests that switching from epoetin-α to other epoetins, including biosimilar and originator versions, in patients with CKD is effective and safe. These results may be very useful to support clinical decisions related to switching drug therapies and promote better health policies to improve the uptake of biosimilars in the population.
Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest, except for Rosa Gini, who disclosed a personal interest in sustainability of universal healthcare systems.
Abstracted by Valeria Belleudi, researcher at the Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
Editor’s comment
Readers interested to learn more about biosimilars in Italy are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
Biosimilars in Italy: what do real-world data reveal?
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Reference
1. Belleudi V, Trotta F, Addis A et al. Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study. Drug Saf 2019. Jun 21. doi: 10.1007/s40264-019-00845-y.
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