Roche, one of the world’s leading manufacturers of medicinal products, and Pharmstandard, a leader of Russian pharmaceutical industry, announced the signing of Supply and Manufacturing Contract and License Agreement aimed at providing the full-cycle localization of Gazyva®, and also signed a Memorandum of Intent in the area pharmaceutical exports.
Taking into consideration the extensive collective experience of establishing advanced drugs manufacturing in Russia according to the good practices and international standards, the companies are focusing on further localization of Gazyva® (obinutuzumab) to manufacture the finished dosage form for the treatment of patients with chronic lymphocytic leukemia and follicular lymphoma.
The manufacturing of the finished dosage form of Gazyva® (obinutuzumab, concentrate for solution for infusion, 1000 mg / 40 ml) will be located at the facilities of Pharmstandard-UfaVITA plant in the Republic of Bashkortostan. The first batches of Gazyva® will be ready at the end of 2018.
The manufacturing of Gazyva® in the Russian Federation will allow to provide the necessary treatment for Russian patients by shortening the waiting period for the drug and, thereby, improving the availability of advanced therapies, while the future plans for supplies outside Russia can contribute to expanding the share of Russian-made pharmaceutical products in the total Russian non-commodity exports, as well as to developing the export capacity of the Russian Federation in general.