165 KB16 KB200520252015Štrukelj, Borutštevilka:3letnik:66str. 256-259ISSN:0014-8229COBISSID:3907185URN:URN:NBN:SI:doc-SY15GDWBslSlovensko farmacevtsko društvoFarmacevtski vestnikbiološka zdravilaefficiencykakovostneprimerljiva biološka zdravilapodobna biološka zdravilaučinkovitostVarnost, kakovost in učinkovitost originalnih in podobnih bioloških zdravil| Safety, quality and efficacy of biologicals and biosimilars|The development of biologicals and biosimilars was expanded in last several years and thus, enabled the better choice of modern target protein-based medicinal products. Due to the parenteral route of administration, all biologicals and biosimilars should fulfill the rigorous criteria regarding safety, efficacy and quality. Al requirements are combined within the procedure of centralized registration regime that was introduced by Agency formedicines EMA in London. The very strict regulatory requirements in EU prevent the entry of non-comparable biologics that might represent a serious treat for patientsRazvoj bioloških zdravil in podobnih bioloških zdravil je v zadnjih nekaj letih omogočil še večjo izbiro tarčnih zdravilnih učinkovin s proteinsko strukturo. Zaradi parenteralnega vnosa so biološka in podobna biološka zdravila podvržena rigoroznim zahtevam po varnosti, učinkovitosti in kakovosti. Vse to omogoča centraliziran postopek registracije bioloških in podobnih bioloških zdravil na Agenciji za zdravila EMA. Prav striktna regulativa na področju registracije zdravil preprečuje prodor neprimerljivih bioloških zdravil, ki bi lahko resno ogrozila varnost bolnikov v EUTEXTznanstveno časopisjejournalsSlovenian National E-content AggregatorNational and University Library of SloveniaSlovensko farmacevtsko društvo