Safety concerns of biosimilar hormone products.

Safety concerns of biosimilar hormone products.
Curr Med Res Opin. 2018 Nov 23;:1-14
Authors: Soldatov AА, Avdeeva JI, Kryuchkov NA, Skosyreva ES
Abstract
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. Biosimilar medicines of human growth hormones, follicle stimulating hormones and insulins were registered in EMA. During development of biosimilar hormone medicines, differences in the profile of glycosylation between biosimilar and reference preparations were revealed. As biotherapeutical preparations are produced by cells, the differences in glycosylation profile between biosimilar and referent preparation are predictable. While carrying out clinical studies, a high similarity of biosimilar and reference products effectiveness is shown, but some differences between them in the safety profile are revealed. The study of biosimilar products safety has shown the necessity of the further improvement of safety and standard approaches assessment for characteristic of biosimilar products immunogenicity.
PMID: 30466327 [PubMed - as supplied by publisher]

Source: Current Medical Research and Opinion - November 25, 2018 Category: Research Tags: Curr Med Res Opin Source Type: research