Background The concept of biosimilar presents a myriad of issues such as patient safety, efficacy and financial aspects to clinicians, pharmacists and policy makers. The introduction of biosimilar infliximab, the first biosimilar on the local national health system in Malta, put clinicians at the forefront of these challenges.
Objectives The objective of the study was to assess the perception and awareness of Maltese clinicians working within the National Health System on the concept of biosimilars.
Methods The questionnaire developed by the Alliance for Safe Biologics Medicines and which was previously run in 5 European countries was shortlisted to be used in the study1. Permission from the Alliance for Safe Biologics Medicines was sought to use the questionnaire. The questionnaire was sent online to prescribing clinicians working within the Maltese National Health System. The clinicians were given one month to answer the questionnaire during which time three reminders were forwarded.
Results A total of 132 prescribers participated in the study giving a 14% response rate. Approximately 34% prescribed biologics within their practice whereas 40% treated patients prescribed biologics by another specialist. Out of the total respondents 6% consider themselves very familiar with the concept of biosimilars, 35% had a basic understanding of biosimilars whereas 59% could not define biosimilars or had never heard of them. Less than half of the respondents (36%) believe that patients can safely receive either originator or biosimilar and expect the same result. Only 27% agree that patients can safely be switched between products during the course of treatment and 46% state that is is very important or critical for them to have the sole authority to decide whether to prescribed the biosimilar or originator. Around 27% answered that they prescribe by generic name irrespective of whether the drug is a biologic or not.
Conclusions The awareness (6%) on biosimilars in Malta is much less than that achieved in 5 European countries where an average of 22% of prescribers considered themselves very familiar with the concept of biosimilars1. Although prescribing of biologic medicines is regulated by Subsidiary Legislation 458.59 “Prescribing and Dispensing requirement rules”, Maltese prescribers are unaware that biosimilars should be prescribed by brand name. Switchability is an aspect where Maltese clinicians are not comfortable since only 27% believe that patients can be safely switched between products during treatment. This however correlates to results of the ASBM European survey where only 39% agree with switchability. Increased awareness on biosimilars together with more robust data on switchability will help Maltese clinicians adopt biosimilars in their practice without having concerns on patient safety and efficacy.
O'Dolinar M, Reilly MS. Biosimilars naming, label transparency and authority of choice - survey findings amongst European physicians. GaBI Journal. 2014;3(2):58–62.
Acknowledgement Mr Michael Reilly, Executive Director, Alliance for Safe Biologics Medicines
Disclosure of Interest None declared