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. 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. 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. 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. Uvod: Podobna biološka zdravila so trenutno realnost farmacevtskega trga v Evropski uniji. Članek opisuje trenutno zakonodajno politiko pridobitve registracij podobnih bioloških zdravil v državah Evropske unije in v Srbiji, ki ni članica EU. Izvedena je bila tudi podrobna analiza porabe podobnih bioloških zdravil na srbskem trgu. Evropska agencija za zdravila je uvedla vrsto znanstvenih smernic za registracijo bioloških zdravil, ki veljajo za zakonodajo na tem področju v Evropski uniji. To je omogočilo registracijo številnih podobnih bioloških zdravil in farmacevtski trg v državah Evropske unije velja za enega izmed najrazvitejših na svetovni ravni. V članku je opisano zakonodajno okolje s poudarkom na vseh pomembnih regulatornih smernicah in tudi analiza registriranih podobnih bioloških zdravil. Prav tako je narejena analiza predpisanih regulatornih zahtev za pridobitev registracij in trženje podobnih bioloških zdravil v Srbiji; izvedena je bila tudi analiza porabe registriranih zdravil v Srbiji prek podatkov srbske agencije za zdravila in zavoda za zdravstveno zavarovanje. V članku je predstavljena celovita analiza trenutnega zakonodajnega okolja v državah Evropske unije in v Srbiji s poudarkom na tržnem potencialu podobnih bioloških zdravil v Srbiji. Prav tako je podana podrobna analiza porabe bioloških zdravil za obdobje 2007-2011. Srbija ima dober potencial za podobna biološka zdravila, ki so podprta z nacionalno zdravstveno politiko zavarovanja in s splošnim trendom zmanjševanja povračil stroškov za zdravila na recept. Petletni podatki o porabi podobnih bioloških zdravil v Srbiji kažejo, da je srbski trg zelo majhen v njihovi porabi, še posebej v primerjavi z drugimi večjimi evropskimi trgih podobnih bioloških zdravil.