Ministry of Industry and Trade intends to expand the production of drugs for orphan diseases


The Russian Ministry of Industry and Trade will study the possibility of expanding the production of preparations for orphan (rare) diseases in the country, TASS reports citing the head of the department Denis Manturov.

“Expansion of production, like new developments, requires serious investments and additional state support measures, and we are ready for carefully study this issue. As part of the project of the Pharma-2030 strategy, a number of measures are also envisaged aimed at further developing this direction, “Manturov quoted the agency as saying.

According to him, there are developments for the treatment of spinal-muscular atrophy in Russia, the drug is potentially able to provide a long-term or even lifelong effect.

The Minister added that domestic manufacturers have serious competencies that allow to reduce the cost and increase the availability of therapy for rare diseases.

“For example, over the past few years, with state support, preparations for the treatment of orphan diseases such as adalimumab, dornase alpha, imiglucerase, eculizumab have been registered and put on the market, the production which is carried out in a full production cycle, including the synthesis of a pharmaceutical substance. The entry into the market of such domestic drugs makes it possible to guarantee the reliability and timeliness of patient care, and also significantly increases patient coverage with the necessary therapy by reducing the cost of treatment, “he said.

The Minister noted that with the support of the state, a line of recombinant human blood factors was developed.

According to the Ministry of Industry and Trade, 34 INN of orphan drugs are registered in Russia, a third of them can be technologically produced according to the full production cycle, including the synthesis of a pharmaceutical station. At the end of 2020, according to analytical agencies, sales of segment drugs amounted to 3.95 million packages worth 42.34 billion rubles. The share of domestic drugs in the total segment sales amounted to 80% in packages and 37% in rubles. In 2020, 14 INN orphan drugs were produced at Russian sites.


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