Abstract
Characteristics of Copaxone (glatiramer acetate, GA) an immunomodulatig drug for the treatment of a heavy autoimmune CNS disease – multiple sclerosis – are presented. GA is acetate of a mixture of synthetic polypeptides of various lengths composed of natural amino acids L-alanine, L-lysine, L-glutamine, and L-tyrosine (20 – 200 amino acids with average m.w. of 5000 – 9000 Da) in stable molecular ratios. The amino acid sequence is controlled predominantly by the polymerization reaction conditions. The molecular masses of most polypeptides are distributed within 2500 – 20000 Da. Copaxone is produced under strictly controlled laboratory conditions or in commercial production process. Analysis of data available on the chemical structure, pharmacological properties, toxicological aspects of GA and its analogs (glatiramoids) shows that, at present, the creation of Copaxone generics is practically impossible.
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