AstraZeneca, a biopharmaceutical company, announced that it registered new maximum ex-work prices in Russia for the tablets of Nexium (esomeprazole) included in the List of Vital and Essential Drugs (VED List).
The state registration of generic drugs in the form of concentrates for solutions will no longer require a report on bioequivalence studies. A relevant draft law was adopted by the Russian State Duma in the first reading.
Cuban Ministry of Health (CECMED) approved for registration the biosimilar of rituximab manufactured by BIOCAD, a Russian biotech company. Supplies of this drug to Cuba are scheduled for the end of 2018.
It will be possible to register drugs that have the same international nonproprietary names, but different trade names, and being manufactured at the same site. The corresponding government bill was adopted by the State Duma.
This was announced by Sergey Glagolev, the Head of the Division for Monitoring the Efficacy and Safety of Medical Products, the Department of the State Quality Control of Medical Products of Roszdravnadzor.
The Board approved the passport and procedure for maintaining the reference book of international nonproprietary names. The decision provides for its inclusion in the EAEU unified regulatory and reference information system.
Servier announced that sales of Effient®, its innovative last-generation antiplatelet agent, began in Russia in March 2018. The license agreement covering the territory of Russia was signed with Daiichi Sankyo in July 2016.