Rationale behind use of biosimilar medicines

Abstract

Being unable to replicate biologics due to their heterogeneity, biosimilars face controversies regarding their application. This study consists of a hybrid qualitative and quantitative approach in order to assess the controversies associated with biosimilar medications, specifically in terms of interchangeability, switching, and substitution. The knowledge and attitude of health care professionals practicing in Malta namely, physicians and pharmacists, were evaluated via questionnaire in order to gauge the assimilation of biosimilars in the medical field throughout the years. Information surrounding the procurement of biosimilars was obtained via an interview with the Central Procurement and Supplies Unit and was compared against the data gathered from the questionnaires. There was an initial increase in familiarity surrounding biosimilars with 90% of physicians feeling ‘very familiar’ and ‘somewhat familiar’ on the topic. However, 45% of physicians preferred to start biotherapeutic treatments on bio-naive patients with the original reference product while only 10% favoured starting treatments with a biosimilar. A contributing factor to their low acceptance rate can be attributed to the issues highlighted during the interview where it was emphasised that a lack of guidance and policies can lead to chaotic state in which confidence in these products becomes impaired. The data gathered from the questionnaires revealed a knowledge gap in both physicians and pharmacists where majority of these health care professionals incorrectly believed that biosimilars were approved for all the same indications as the originator. Furthermore, half of the physicians believed the originator and the biosimilar were structurally identical while 73.6% of pharmacists knew there were structural differences. While the harmonisation of guidelines is not something that can be easily implemented without the alignment of regulatory authorities, allocating more resources towards educating health care professionals surrounding the topic of biosimilars would help aid in the uptake of these agents.