BiologiC Drugs: WHAT’S the difference?

Kovalenko V.N.1, Bortkevych O.P. 2, Rekalov D.H.3, Medvedchuk G.Y.3

Summary. Summary. Biological agents (BA) — a group of drugs with the possibility of molecular diversity. To date, a whole series of BA molecular patent expires. Given that, the newly emerging BA intended as a replacement biosimilars may, to a limited extent, differ in the manufacture process (variations in the immunogenicity, safety and/or efficacy) — a clear understanding of the clinical and regulatory aspects of the originators and intended copies is very important.

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