Biosimilars – current knowledge on their interchangeability


Authors: D. Vetchý 1;  M. Vetchá 2
Authors‘ workplace: Ústav technologie léků, Farmaceutická fakulta, Veterinární a farmaceutická univerzita, Brno 1;  Lékárna Na Mendlově náměstí, Brno 2
Published in: Čes. Revmatol., 21, 2013, No. 4, p. 200-205.
Category: Comments

Overview

The biosimilars cannot be regarded as chemical generics, because, unlike the latter ones, they are not and cannot be chemically identical to the original product. Even seemingly small differences in manufacturing of biosimilars may affect the immunogenic response. To date, there is little known about the mechanism of immunogenic responses. It has been pointed out that the acute therapy may be more immunogenic than the chronic one. Furthermore, experts incline to the belief that the intermittent administration is more likely to cause an immune response than continuous therapy, and that the theory of aggregation and detection of foreign epitopes as the main risk factor for immunogenicity is too simplistic. It is currently not possible to identify a direct safety risk associated with the substitution of biological drugs, because there is very little data dealing with this issue. It has been repeatedly confirmed that biological agents are not simply interchangeable even within the same ATC group due to their indications, side effects, and safety profiles that have been studied in the individual clinical trials designed specifically for every product. The current consensus in some EU countries is to treat the patient with the same agent until the urgent reasons force a change in the treatment.

Key words:
biosimilars, interchangeability of biosimilars, production of biosimilars, registration of biosimilars, immunogenicity


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Labels
Dermatology & STDs Paediatric rheumatology Rheumatology
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