Анализ проблемы регулирования доступа к биосимилярам и пути решения

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.