Russian companies developed and submitted to the Minister of Health Veronika Skvortsova a proposal of rules governing studies of biosimilars
A number of Russian companies including BIOCAD, Generium, GEROPHARM, ChemRar, R-pharm, Sotex, Pharmstandard and others developed Rules for conducting studies of biosimilars.
The document was submitted to the Russian Minister of Health Veronika Skvortsova on September 10. The rules were developed based on documentation from EU, USA and WHO and in collaboration with international experts.
The new rules are as specific and detailed as possible. This will ensure high regulatory standards and will guarantee that only safe and effective biologics enter the Russian market.
Source: Pharmvestnik