Ostalo
WHAT DOCTORS NEED TO KNOW ABOUT BIOSIMILAR MEDICINAL PRODUCTS?
PETAR KES
; Klinički bolnički centar Zagreb, Interna klinika, Zavod za nefrologiju, arterijsku hipertenziju, dijalizu i transplantaciju, Zagreb, Hrvatska
INES MESAR
; Klinički bolnički centar Zagreb, Interna klinika, Zavod za nefrologiju, arterijsku hipertenziju, dijalizu i transplantaciju, Zagreb, Hrvatska
NIKOLINA BAŠIĆ-JUKIĆ
; Klinički bolnički centar Zagreb, Interna klinika, Zavod za nefrologiju, arterijsku hipertenziju, dijalizu i transplantaciju, Zagreb, Hrvatska
SANJIN RAČKI
; Klinički bolnički centar Rijeka, Klinika za internu medicinu, Zavod za nefrologiju i dijalizu, Rijeka, Hrvatska
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
Datum izdavanja:
14.9.2014.
Posjeta: 2.896 *