At the end of February, it became known that the pharmaceutical company “Biotek” will become a supplier of the drug for the treatment of spinal muscular atrophy (SMA) nusinersen (TN Spinraza from Biogen and Janssen) for the sum of 128.8 million rubles for the charitable foundation “Circle of Good”. In addition to nusinersen, risdiplam (Eurisdi from Roche) and not yet

As mentioned in our last article, within the framework of bringing the dossier into compliance with the requirements of the EAEU, it may be necessary to provide the patient leaflet (PL) and the results of readability test (more on this: https://beawire.com/ru/2020/09/21/procedure-for-bringing-the-registration-dossier-in-line-with-the-requirements-of-the-eaeu/). In this article we will try to elaborate on the readability test and the necessary format of its provision.

As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of drugs as reference (= Brand name), generic and biosimilar drugs. According to statistics, more than 60% of drugs on the Russian market are generics, or reproduced drugs. Definitions According to the Federal Law 61 reference drug is called a