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WHAT DOCTORS NEED TO KNOW ABOUT BIOSIMILAR MEDICINAL PRODUCTS?

PETAR KES ; Zagreb University Hospital Center, Department of Nephrology, Hypertension, Dialysis and Transplantation, Zagreb, Croatia
INES MESAR ; Zagreb University Hospital Center, Department of Nephrology, Hypertension, Dialysis and Transplantation, Zagreb, Croatia
NIKOLINA BAŠIĆ-JUKIĆ ; Zagreb University Hospital Center, Department of Nephrology, Hypertension, Dialysis and Transplantation, Zagreb, Croatia
SANJIN RAČKI ; Rijeka University Hospital Center, Department of Internal Medicine, Department of Nephrology and Dialysis, Rijeka, Croatia

Puni tekst: hrvatski, pdf (102 KB) str. 201-205 preuzimanja: 733* citiraj
APA 6th Edition
KES, P., MESAR, I., BAŠIĆ-JUKIĆ, N. i RAČKI, S. (2014). ŠTO BI LIJEČNICI TREBALI ZNATI O BIOLOŠKI SLIČNIM LIJEKOVIMA?. Acta medica Croatica, 68 (2), 201-205. Preuzeto s https://hrcak.srce.hr/126815
MLA 8th Edition
KES, PETAR, et al. "ŠTO BI LIJEČNICI TREBALI ZNATI O BIOLOŠKI SLIČNIM LIJEKOVIMA?." Acta medica Croatica, vol. 68, br. 2, 2014, str. 201-205. https://hrcak.srce.hr/126815. Citirano 21.01.2020.
Chicago 17th Edition
KES, PETAR, INES MESAR, NIKOLINA BAŠIĆ-JUKIĆ i SANJIN RAČKI. "ŠTO BI LIJEČNICI TREBALI ZNATI O BIOLOŠKI SLIČNIM LIJEKOVIMA?." Acta medica Croatica 68, br. 2 (2014): 201-205. https://hrcak.srce.hr/126815
Harvard
KES, P., et al. (2014). 'ŠTO BI LIJEČNICI TREBALI ZNATI O BIOLOŠKI SLIČNIM LIJEKOVIMA?', Acta medica Croatica, 68(2), str. 201-205. Preuzeto s: https://hrcak.srce.hr/126815 (Datum pristupa: 21.01.2020.)
Vancouver
KES P, MESAR I, BAŠIĆ-JUKIĆ N, RAČKI S. ŠTO BI LIJEČNICI TREBALI ZNATI O BIOLOŠKI SLIČNIM LIJEKOVIMA?. Acta medica Croatica [Internet]. 2014 [pristupljeno 21.01.2020.];68(2):201-205. Dostupno na: https://hrcak.srce.hr/126815
IEEE
P. KES, I. MESAR, N. BAŠIĆ-JUKIĆ i S. RAČKI, "ŠTO BI LIJEČNICI TREBALI ZNATI O BIOLOŠKI SLIČNIM LIJEKOVIMA?", Acta medica Croatica, vol.68, br. 2, str. 201-205, 2014. [Online]. Dostupno na: https://hrcak.srce.hr/126815. [Citirano: 21.01.2020.]

Sažetak
Biological drug is a drug containing one or more active substances produced or secreted from a biological source. Some of them may be previously present in the human body, and examples include proteins such as insulin, growth hormone or erythropoetin. Biosimilar drug is a medical product that is a copy of the original approved drug whose patent has expired. Strict rules apply to similar biological medicines: 1) it is unable to support extrapolation of data on safety and efficacy between individual indications, except in the case of appropriate, science-based evidence; 2) biosimilar drugs must meet the requirements associated with testing the immunogenicity and safety monitoring after the introduction of the drug in clinical practice, including the risk management program; 3) each biosimilar drug has to be labeled under its own name in order to allow clear traceability of all medications; and 4) the principle of automatic substitution cannot apply to biosimilar drugs because they are not interchangeable.

Ključne riječi
biological medicine; biosimilar drug; efficacy; safety

Hrčak ID: 126815

URI
https://hrcak.srce.hr/126815

[hrvatski]

Posjeta: 972 *