Janssen localizes the manufacturing of Imbruvik in Russia

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Janssen, a pharmaceutical unit of Johnson & Johnson, confirmed its intention to localize the portfolio of innovative drugs for the treatment of malignant blood diseases, including the localization of Imbruvik (ibrutinib) used in the therapy of chronic lymphocytic leukemia, mantle cell lymphoma, Waldenstrom macroglobulinemia and marginal zone lymphoma.

The drug was recognized as a “breakthrough innovation” and awarded the Prix Galien in several countries, including Russia. The use of this drug allows more than half of patients, for whom the standard therapy is ineffective, to live 5 or more years, which is a real breakthrough in the therapy of the refractory forms of chronic lymphocytic leukemia.

“In Russia, the drug has already been successfully used in 350 patients, and our goal is to make it available for the maximum number of patients suffering from these serious diseases. To this end, together with Pharmstandard, we are already localizing the secondary packaging of Imbruvik at OJSC Pharmstandard-UfaVITA plant, which is reflected in the marketing authorization,” said Katerina Pogodina, the Managing Director of Janssen Russia and CIS.

Grigory Potapov, the General Director of JSC Pharmstandard, said, “At this time, the chronic lymphocytic leukemia is the only oncohematological disease not included in the 7 High-Cost Nosology program, which provides targeted therapy for the patients.  We understand how important is the local status of the product for expanding its availability to patients, and we are currently assessing the technical and technological possibility of localizing the full cycle manufacturing of the finished dosage form of Imbruvik to continue the significant work on the transfer of methods and technologies that we have done in order to localize the secondary packaging.”

SOURCE: gmpnews.ru
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