Evaluation of the drug utilization of biosimilar medicinal products containing monoclonal antibodies: A systematic review

Abstract

Aim: The objective is to study the availability and affordability of biosimilar medicinal products containing monoclonal antibodies, measure their drug utilization, and evaluate the rational drug use globally through analysis and systematic review of scientific articles published in the scientific literature. Materials and methods: The documentary analysis of scientific publications was carried out by specific keywords in MEDLINE database, Central Medical Library, and national peer-reviewed scientific journals in Bulgaria for the period from January 2008 to May 2020. 100 scientific publications have been found for a period of 12 years. Articles were selected according to PRISMA. Analyses include 17 articles that fully meet the preset criteria. Descriptive and variational analyses were carried out as basic statistical analyses. Mean values, standard deviation, minimum, maximum, and 95% confidence intervals have been determined. Results and discussion: Studies on this topic in EU Member States are obviously of interest, but publication activity is not high—only 17 scientific publications over a 12-year period. All 17 studies reflect cost savings after switching from a reference biological medicinal product to a biosimilar medicinal product, and the reduction in budgetary costs as a weighted average is about 30% of the total budgetary costs of biological therapies for the first 5 years. All 17 studies have reported that the use of biosimilar medicinal products is rather low. Although the quality, safety, and efficacy of biosimilar medicinal products have been unequivocally established, their introduction to the market is still insufficient.