CURRENT REGULATORY AND MARKET ENVIRONMENT FOR BIOSIMILARS IN SERBIA

Background: Biosimilars are currently a reality of the pharmaceutical market in the European Union. This paper describes the current regulatory policy for approving biosimilars both in the European Union and in Serbia, which is not a Member State. Also, a comprehensive analysis on biosimilars consumption data on the Serbian market has been performed. Methods: The European Medicines Agency has established a series of biosimilar scientific guidelines that comprises a regulatory policy for biosimilars in the European Union. This has enabled different biosimilar products to be marketed, making the European Union biosimilar market the most developed one globally. In the paper, this regulatory environment has been analysed, emphasising all relevant biosimilar guidelines as well as marketed biosimilar medicines. Also, an analysis is performed on Serbian regulatory requirements for approving and marketing biosimilars, analysing the Serbian regulatory authority's consumption data as well as data available from the National Health Insurance Institution. Results: In the paper, the comprehensive analysis of the current European Union as well as Serbian regulatory environment has been presented, with a special emphasis on the Serbian market potential for biosimilar medicines. Detailed consumption data has been analysed for the period 2007-2011. Conclusion: Serbia has good potential for biosimilar products, which is supported by national health insurance policy and the general trend of cutting the reimbursement costs for prescription medicines. Five year consumption data for biosimilars in Serbia shows that the Serbian biosimilars market is very small in terms of market share values, especially comparing to other large European biosimilar markets.