Options to optimize the access to biosimilars: analysis and solutions

Abstract

The cost of medical care has been growing around the world; this is due to a number of factors, including the growing use of costly medicines for cancer and rare (orphan) diseases. The introduction of reproduced medicinal products instead of original ones opens the way to medical cost reduction. In the present study, various aspects of registration and application of reproduced biological medicinal products – biosimilars – in the Russian Federation and elsewhere (USA, EU) are addressed. We propose the basic approaches to optimize the access to biological preparations and their analogs (biosimilars) considering the existing increase in medical costs and the need to maintain the quality of medical care.

Keywords

• biosimilars
• registration
• reproduction
• replaceability
• generics