Lege Artis Medicinae

[Clinical pharmacologic principles and problems related to the clinical use of innovative and similar biological medicines]

KERPEL-FRONIUS Sándor

AUGUST 20, 2010

Lege Artis Medicinae - 2010;20(08)

[The active substances in the biological medicinal products are macromolecules, primarily proteins most of which are currently produced by various biotechnological methods in different biological systems. The spatial structure of the macromolecular active substances cannot be accurately determined by the presently available methods. Therefore, both physico-chemical and biological methods are needed for the control of their quality and production. The active proteins induce immunologic reactions in the organism. The appearance of neutralizing antibodies frequently leads to the inhibition of the effect of the biological medicines. The European Medicines Agency (EMA) registers the medicinal products containing similar macromolecular active substances produced by biotechnological methods as biosimilar agents, since their chemical identity cannot be proven. The similarities and differences of their biological and immunological effects can be evaluated only in comparative non-clinical and clinical trials. The frequent exchange of biological medicines increases the appearance of antibodies in the patients, therefore the substitution of biological drugs should be done only by the treating physicians if clinically necessary.]

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