Roche agreed with Dobrolek LLC (part of Farmeko Group) on the localization of production of an innovative drug in Russia for the treatment of the inhibitory form of hemophilia A emicizumab. The ceremony was held during the opening of the IV All-Russian GMP Conference in Svetlogorsk in the presence of Sergey Tsyb, First Deputy Minister of Industry and Trade.
According to the terms of the agreement, Roche will ensure the transfer of technology for the production of emicizumab, including unique quality control methods, and uninterrupted supply of in-bulk products necessary for production to the Russian Federation. In turn, Dobrolek organizes production in accordance with the Rules of Good Manufacturing Practice (GMP), as well as storage and distribution of the drug in the Russian Federation. As part of the project, the necessary retrofitting of production facilities and laboratories, and staff training will be carried out.
Emicizumab will be produced at the facilities of Dobrolek LLC in Moscow in the form of a solution for subcutaneous administration of 150 mg/ml and 30 mg/ml. The first batch of emicizumab will enter the Russian market in September 2020.
The production capacities of Dobrolek LLC will fully satisfy the needs of Russian healthcare in emicizumab.
“We welcome the development of cooperation between Russian and international pharmaceutical manufacturers in the production of drugs for the treatment of diseases from a list of 12 high-cost nosologies in Russia. This helps to deepen Russia’s integration into world production processes, as well as to expand the competencies and experience necessary for developing the export potential of domestic companies,“
said Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation.