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master's thesis
Biološka terapija i biosimilari u javnim ljekarnama
Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry, 2019. urn:nbn:hr:163:870067
Vrhovac, Marin
University of Zagreb
Faculty of Pharmacy and Biochemistry
Department of pharmacology

Institutional repository: Repository of Faculty of Pharmacy and Biochemistry University of Zagreb

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Vrhovac, M. (2019). Biološka terapija i biosimilari u javnim ljekarnama (Master's thesis). Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry. Retrieved from https://urn.nsk.hr/urn:nbn:hr:163:870067

Vrhovac, Marin. "Biološka terapija i biosimilari u javnim ljekarnama." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2019. https://urn.nsk.hr/urn:nbn:hr:163:870067

Vrhovac, Marin. "Biološka terapija i biosimilari u javnim ljekarnama." Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, 2019. https://urn.nsk.hr/urn:nbn:hr:163:870067

Vrhovac, M. (2019). 'Biološka terapija i biosimilari u javnim ljekarnama', Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, accessed 29 November 2024, https://urn.nsk.hr/urn:nbn:hr:163:870067

Vrhovac M. Biološka terapija i biosimilari u javnim ljekarnama [Master's thesis]. Zagreb: University of Zagreb, Faculty of Pharmacy and Biochemistry; 2019 [cited 2024 November 29] Available at: https://urn.nsk.hr/urn:nbn:hr:163:870067

M. Vrhovac, "Biološka terapija i biosimilari u javnim ljekarnama", Master's thesis, University of Zagreb, Faculty of Pharmacy and Biochemistry, Zagreb, 2019. Available at: https://urn.nsk.hr/urn:nbn:hr:163:870067

Metadata
TitleBiološka terapija i biosimilari u javnim ljekarnama
Title (english)Biologic therapy and biosimilars in pharmacy
AuthorMarin Vrhovac
MentorPetra Turčić (mentor)
Committee memberPetra Turčić (predsjednik povjerenstva)
Committee memberZrinka Rajić (član povjerenstva)
Committee memberDavor Šakić (član povjerenstva)
GranterUniversity of Zagreb
Faculty of Pharmacy and Biochemistry
(Department of pharmacology)
Zagreb
Defense date and country2019-09-30, Croatia
Scientific / art field,
discipline and subdiscipline		BIOMEDICINE AND HEALTHCARE
Pharmacy
Pharmacy
Abstract
Od lipnja 2019. biološke lijekove adalimumab i etanercept moguće je podizati u ljekarnama na razini primarne zdravstvene zaštite. Biološki lijekovi se proizvode pomoću živih sustava kao što su mikroorganizmi ili kulture stanica dok se kemijski lijekovi dobivaju kemijskom sintezom. Ova činjenica je uzrok mnogih različitosti između navedenih skupina. Biosličan lijek je biološki lijek za koji je dokazana sličnost u pogledu kakvoće, biološke aktivnosti, sigurnosti primjene i djelotvornosti s odobrenim izvornim biološkim lijekom. Adalimumab i etanercept se specifično vežu za TNF i neutraliziraju biološku funkciju TNF-a. Liječenje moraju započeti i nadzirati liječnici specijalisti s iskustvom u dijagnosticiranju i liječenju stanja za koja su lijekovi indicirani. Nakon odgovarajuće poduke o tehnici ubrizgavanja injekcija, bolesnici mogu sami sebi davati injekcije lijeka ako njihov liječnik procijeni da je to moguće provesti, uz medicinsko praćenje po potrebi. Niti jedan od navedenih lijekova nije prva linija liječenja već se koriste u situaciji kad nije postignut zadovoljavajući odgovor na konvencionalno liječenje, kod osoba koje ne podnose konvencionalno liječenje ili u kojih konvencionalno liječenje nije prikladno. Stavovi o biosimilarima kao manje kvalitetnim i njihova percepcija kao lijekova nižeg standarda su znanstveno neutemeljeni. Potencijalna imunogeničnost predstavlja glavni sigurnosni problem, čak i humana protutijela mogu izazvati imunosni odgovor. Rizik od imunogeničnosti postoji kod svih bioloških lijekova, a ne samo kod biosličnih lijekova. Za ekstrapolaciju indikacija ne postoji univerzalni postupak odobravanja za biosimilare. Stoga regulatorne agencije mogu donijeti različite odluke za pojedini lijek. (Ne)mogućnost zamjene bioloških/biosličnih lijekova tijekom trajanja terapije donosi podijeljena stajališta. Većina država članica zauzima stav da izravna zamjena bioloških lijekova koja ne zahtijeva savjetovanje i posebno praćenje liječnika specijalista nije dopuštena.
Abstract (english)
Since June 2019. biological medicines adalimumab and etanercept can be picked up in a pharmacy at the primary health care level. Biological medicines are made using live organisms such as microorganisms or cell cultures while chemical medicines are made using chemical synthesis. This is the cause of many differences between the two. Biosimilar medicine is a biological medicine which has proven similarity regarding quality, biological activity, safety and efficacy to the original biological medicine. Adalimumab and etanercept bind specifically to the TNF and neutralize its biological function. Treatment must begin and be supervised by specialists with experience in diagnosing and treating conditions for which the drug has been approved. After adequate training patients can inject themselves with the medicine if the physician estimates that patient is able to do so, if needed with medical monitoring. None of the before mentioned medicines is used as the first line of treatment but rather in the situation when there is an inadequate response to the conventional treatment, with individuals that can not stand the conventional treatment or when conventional treatment is not appropriate. Opinions regarding biosimilars and their perception as lower quality drugs are scientifically unfounded. Potential immunogenicity is a main health issue, even humanized antibodies can cause an immune response. Immunogenicity risk is present with all biological medicines, not only with biosimilars. For extrapolation of indications a unique procedure for biosimilars approval does not exist. Therefore regulatory agencies can come to different conclusions regarding a medicine. (In)ability to substitute biological/biosimilar medicine during the duration of the treatment has opposing views. Most of the countries decided that automatic substitution of biological medicines which does not require consultation and special monitoring by a specialist is not allowed.
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:163:870067
Study programmeTitle: Pharmacy
Study programme type: university
Study level: integrated undergraduate and graduate
Academic / professional title: magistar/magistra farmacije (magistar/magistra farmacije)
Type of resourceText
File originBorn digital
Access conditionsOpen access
Terms of useLicence In copyright icon
Created on2021-04-23 07:34:46