Author/Editor		Štrukelj, Borut
Title		Varnost, kakovost in učinkovitost originalnih in podobnih bioloških zdravil
Translated title		Safety, quality and efficacy of biologicals and biosimilars
Type		članek
Vol. and No.		Letnik 66, št. 3
Publication year		2015
Volume		str. 256-259
ISSN		0014-8229 - Farmacevtski vestnik
Language		slv
Abstract		Razvoj 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 EU.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 patients.
Keywords		biološka zdravila podobna biološka zdravila neprimerljiva biološka zdravila učinkovitost kakovost