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.