International Medical Journal, Vol. 20., Iss. 1, 2014, P. 81−88.
ORIGINAL AND GENERIC DRUGS: MYTHS AND REALITIES
N.I. Pirogov Russian Research Medical University, Moscow, Russian Federation
A wide use of generics is a world−wide tendency at present. This raises important questions to the producers of reproduced drugs, in particular, if it is possible to obtain a copy of the original of high quality, if it is guaranteed that the generic will have similar to the basic drug therapeutic efficacy and safety, etc. Permission to produce generics is based on the assumption that it will be equivalent to the original by its pharmaceutical and pharmacokinetic features (absorption, distribution, metabolism and excretion of the active component). Therapeutically equivalent are the generics meeting FDA criteria, which annually publishes the lists of permitted drugs in the Orange Book. A high−quality copy of the original drug can be obtained if pharmacologically active substances making up the generic will have a simple chemical nature, its pharmacokinetics will be linear, the production standard will correspond to high quality and control (GMP), producer transparency (open access to the primary data on bioequivalence, correspondence to specifications). It is also important to compare and assess the composition and quality of adjuvants in various reproduced drugs as to their correspondence to international pharmacopeia and the composition of then original drug. This question at the Russian and European market requires further analysis.
Key words: original drug, generic, bioequivalence, therapeutic equivalence.