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18.12.2017

Roche may bear losses in Russia over Gaziva

Swiss pharmaceutical giant Roche (ROG: SIX), which invested 1.5 billion roubles ($25 million) in the localization of the production of its anti-cancer drug Gaziva/Gazyvaro (obinutuzumab) in Russia in order to participate in public procurements, may not implement its plans, reports The Pharma Letter’s local correspondent.

The expensive drug was not included in the program of seven high-cost nosologies, as the Russian Ministry of Health says the manufacturer did not provide all the necessary documentation.

This has been recently confirmed by general director of the Russian office of Roche, Nenad Pavletich.

To organize full-cycle production of the drug, which is currently carried out at the facilities of the Pharmstandard plant in Ufa, the company invested 1.5 billion roubles. Pharmstandard, for its part, has invested 1 billion roubles.

Mr Pavletich said the partners planned to make the first deliveries of the drug, designed for patients with lymphocytic leukemia and lymphoma, at the beginning of 2019 for state procurement under the program of seven high-cost nosologies (VZN).

Deliveries will be carried out following the results of the tenders, which are due in late 2018. But the Russian government did not include Gaziva in the relevant list of drugs planned for public procurements that will be valid until the end of 2018. Without it, the company will not be able to supply the drug as part of public procurements.

This project would have become the first case of production of Roche drugs in Russia on a full-cycle basis. The company planned to produce about 20,000 packages of Gaziva for the Russian market every year, and also to start its exports. According to Mr Pavletich, it is impossible to return investments only by exporting the drug abroad.

In the meantime, a spokesman of the Russian Ministry of Health explained that Roche did not provide enough data for the clinical and economic parameters of the drug to be included in the list. He added that, if the necessary documents are submitted, the state commission is ready to revise its earlier decisions.

Experts of the Russian Ministry of Health believe such situations are not uncommon in the Russian pharmaceutical market. They believe foreign companies, whose production facilities are not localized in Russia, have little chance of entering the public procurement market. Experts see the only way to solve the problem is to transfer Gaziva to Pharmstandard, which will try to promote the drug, while sharing risks with Roche.

Currently the cost of Gaziva in the Russian market is estimated at 200,000 roubles ($3,300) per package.


Source:  www.thepharmaletter.com

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