Roche and R-Pharm Group signed an agreement on the localization of okrelizumab (Okrevus®) production in Russia. The signing ceremony took place during the opening of the IV All-Russian GMP-conference in Svetlogorsk in the presence of the First Deputy Minister of Industry and Trade of the Russian Federation Sergey Tsyb.
According to the terms of the agreement, Roche will ensure the transfer to R-Pharm of Okrelizumab production technologies, including unique quality control methods, and uninterrupted supply of products necessary for production to the Russian Federation. In turn, R-Pharm will organize production in accordance with the Rules of Good Manufacturing Practice (GMP), as well as storage and distribution of the drug in the Russian Federation.
Okrelizumab will be produced at the facilities of R-Pharm Group. The manufacturing process will include secondary packaging and issuing quality control. The first batch of okrelizumab will enter the Russian market in September 2020.
The production capacities of R-Pharm will fully satisfy the needs of the Russian healthcare in okrelizumab. The corresponding application was sent by Roche to the Commission for the formation of lists of drugs for medical use.