Safety concerns of biosimilar hormone products.

Background: Currently, biotherapeutic medicines are the most effective options for the treatment of many severe and chronic diseases. For faster market entry of biotherapeutic products and their cost reduction, the principles of "biosimilarity" have been developed. Development and licensing of biosimilars is allowed only after the end of patent exclusivity of the original preparation period.

Presence of cytokines in biological preparations.

In vaccines produced in eukaryote cells as well as in commercial medical preparations of leukocyte interferon a number of cytokines such as IL-1beta, IL-6 and TNF-alpha have been detected. Among the vaccines examined in this study the highest level of IL-1beta was demonstrated in inactivated hepatitis A vaccine prepared in the green monkey kidney cell line 4647, that of IL-6 in inactivated rabies vaccine produced in Syrian hamster kidney (SHK) cell culture, and that of TNF-alpha in live poliomyelitis vaccine manufactured in VERO cells. A spontaneous and poliovirus-induced capacity of cell cultures to produce cytokines was detected.