The real concern for your future

Manufacture of domestic generics provides an opportunity for the government to save


Russian company AO "Pharm-Sintez" has completed the development and registration of the domestic anti-tumor drug, Milanfor, for the treatment of multiple myeloma (hematologic malignancy) – the first generic product (analogue) of the foreign drug Velcade. The active ingredient of this drug is bortezomib. It was developed by the team of Russian scientists. The entire technological cycle for this drug, including synthesis and manufacture of the substance, is carried out on the territory of the Russian Federation.

 It is apparent that the introduction of high-quality and effective generics provides healthcare authorities with an opportunity to significantly reduce expenditures on medicine assistance. The developers estimated that the cost of a treatment course with a domestic generic drug for a patient with multiple myeloma would be 30-40 % cheaper compared to that with the innovator drug.

 Thus, one package of Velcade costs more than 74 thousand rub., based on the results for the year 2008 more than 6 billion rub. were spent for purchasing of this drug product from the state budget.

 According to experts, the participation of the domestic generic product in the public auction for government contracts for the supply in the second half of the year 2009 under the "7 nosologies" state program may help the government to significantly save the state budget.

 Every year about 1000 cases of diagnosed multiple myeloma are registered in our country, accounting for approximately 10-15 % of hematological malignancies. Multiple myeloma is the cause of death of nearly each fifth patient with hematological malignancies, meanwhile more than 25 % of patients with hematologic malignancies die within the first year after diagnosis.

 To a large extent, the high mortality related to hematologic malignancies in Russia is due to lack of assurance of both accessible and highly effective pharmaceutical assistance for citizens. The treatment with bortezomib radically improves survival and quality of life of patients with fatal diseases.

 Given the high social significance of the drug product, it was registered by the Federal Service on Surveillance in Healthcare and Social Development in an expedited manner. The extensive preclinical program showed a complete chemical, pharmaceutical and pharmacokinetic equivalence of generic product to the innovator drug.

 Safety (toxicological) profiles of these drug products were shown to be similar as well. Meanwhile, the expeditious registration of the generic drug was considerably advocated for also by the medical community headed by Andrey Vorobiev, the director of the Hematological Scientific Center of the Russian Academy of Medical Sciences, member of the Russian Academy of Sciences and Russian Academy of Medical Sciences, as reported by the press service of the Association of Russian Pharmaceutical Manufacturers.

 Significantly, the expansion of the sector of domestic expensive anti-tumor drug agents in the home market will contribute to reduction in dependence on supplies and production outputs of the particular foreign manufacturer. This is of the most immediate interest in the shadow of the financial and economic crisis, when the dependence of the industry on imports has resulted in the significant rise in prices for pharmaceuticals.