BiologiC Drugs: WHAT’S the difference?

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

• ¹ГУ «ННЦ «Институт кардиологии им. Н.Д. Стражеско» НАМН Украины», Киев
• ²SI «NSC «Institute of Cardiology M.D. Strazhesko» NAMS of Ukraine», Kyiv
• ³Zaporizhzhya state medical university

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.