Abstract

The importance of biosimilars is increasing as more and more biologicals are losing market exclusivity. Utilization of more affordable multisource biological medicines can improve the allocative efficiency of scarce health care resources. This study aims to evaluate the efficiency of the Hungarian biosimilar drug policy through the uptake of biosimilar infliximab. We evaluated the efficiency of the Hungarian biosimilar drug policy by (1) investigating the uptake of biosimilar infliximab after the originator infliximab has lost market exclusivity, (2) assessing the market penetration of the more affordable biosimilar alternative compared to the original biological infliximab and (3) analysing the switching patterns among different biological medicines in the seven reimbursed indications of infliximab between September 2012 and December 2016 based on data from the public payer’s database. Patent expiry did not manifest in increased utilization of multisource infliximab in any indications. Although those biological treatment naive patients who started infliximab after its patent expiry were treated with biosimilars, majority of new patients started on other original biologicals. Patients previously treated with original infliximab were switched mainly to other original biologicals instead of more affordable biosimilar alternatives. In Hungary, the biosimilar policy did not result in increasing utilization of more affordable multisource biological medicines compared to other original biologicals. In lower income countries with economic constraints (such as countries in Central and Eastern Europe) biosimilar drug policies should incentivize the utilization of more affordable multisource biological pharmaceuticals to improve patient access. The efficiency of policy interventions can be monitored by reviewing the initial therapy of new patients and switching patterns, in addition to facilitation of pharmacovigilance data collection.

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