Unele particularităţi privind regimul juridic al medicamentelor biologice şi biosimilare

Conf. univ. dr. Dan CIMPOERU

Abstract

In a relatively short time, due to the remarkable discoveries in the field of genetic engineering, the biotechnology industry has seen a rapid development. In this context, pharmaceutical companies have recognized the extraordinary innovating potential of biotechnology in the medical field. Unlike conventional medicines that can be reproduced identically in the form of generic medicines, the situation for biological medicines is different: in most cases, the medicines obtained are not identical to the original biological product, they are just “similar" to it (biosimilar). These particularities of biological and biosimilar medicines also determine a different legal regime in terms of substitution, prescription and acquisition.

Keywords: biological medicines, biosimilar medicines, substitution, prescription and acquisition of biological/biosimilar medicines.

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