The impact of implemented regulations on biosimilars in Slovakia.

• There were 47 biosimilars approved by the European Medicines Agency (EMA) between 2006 and September 2018. • In the same period, only 14 reimbursement dossiers from marketing authorisation holders were submitted for biosimilars in Slovakia. • The Slovak health budget could save €28.26-€39.56 million per year if biosimilars with marketing authorisations were available in the Slovak market. • Proactive strategies and policies should be implemented with the aim of increasing the availability and penetration of biosimilars. • The current knowledge and perception among clinicians in Slovakia regarding biosimilars in comparison with original biologics is unknown. The aim of this study was to review legislative provisions for the reimbursement of biosimilars, assess the impact of the implemented regulations on access to biosimilars, and to calculate the lost opportunity for savings due to the limited availability of biosimilars in Slovakia. The Slovak legislation concerning the reimbursement of biosimilars was reviewed. The reimbursement dossiers of medicines, health technology assessments and appraisals, justification of the reimbursement decisions, final reimbursement decisions and all aspects of the appeal mechanisms are transparently published on the website of the Slovak Ministry of Health (http://kategorizacia.mzsr.sk/Lieky), and these were used for this analysis. Only 14 reimbursement dossiers were submitted for biosimilars between 2006 and September 2018 in Slovakia. In 2016 and 2017, no reimbursement dossiers were submitted. The results, based on data provided by wholesalers who are legally obliged to deliver information to the State Institute for Drug Control, showed that the Slovak health budget could save €28.26-€39.56 million per year if biosimilars with marketing authorisations were available in the Slovak market, and a 25–35% decrease in price compared with that of biological medicinal products. Our findings show that proactive strategies and policies should be implemented to increase availability and penetration of biosimilars on the Slovak pharmaceutical market to reduce societal losses that are caused by the lack of biosimilar medicines availability. [ABSTRACT FROM AUTHOR]