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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

Abstract

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.

Keywords

biological medicine; biosimilar drug; efficacy; safety

Hrčak ID:

126815

URI

https://hrcak.srce.hr/126815

Publication date:

14.9.2014.

Article data in other languages: croatian

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