Russia. Branded Generics - The Most Promising Subgroup on the market in 2015-2019

As described in the PMR report “Generic and innovative drugs in CIS countries 2014. Development forecasts for 2014-2019”, branded generic medicines represent the most promising subgroup on the Russian pharmaceutical market. There is a general trend in many Central and Eastern European and Commonwealth of Independent States countries, not only in Russia, toward switching to cheaper generic medicines (branded), accelerated by the expiry of the patents of many blockbusters.

GMP rules will bring a new level of quality

GMP rules which were to be implemented by 2014 will bring a new level of quality to the generic market and will lead to an increase in the proportion of superior branded generics. At the same time, there will be a year-on-year reduction in the share of local cheap unbranded generics – the production of many drugs might come to an end because of the lack of appropriate production standards.

Russian production will focus mainly on generics

In both subgroups – generic and innovative medicines – there will be an increase in domestically-manufactured medicines on the market, in line with Pharma 2020 programme assumptions. Many global pharmaceutical manufacturers (generic and innovative) are planning to establish their production facilities in Russia. Russian manufacturers also intend to expand their production facilities in the country. In our opinion, however, domestic production will focus mainly on biosimilars, high-standard generic equivalents of original medicines or the so-called “me-too” projects (the manufacture of drugs which have an original patented formula which is similar in structure to the molecule of the class founder). Such drugs, including the foremost in terms of efficacy and safety, sometimes differ from class founders only in the way in which they are marketed.

Development of the pharmaceutical and medical industry in Russia for 2013-2020

In April 2014, the government’s “Development of the pharmaceutical and medical industry for 2013-2020” programme from November 2012 was amended in Russia. This is an additional programme within Pharma 2020 scheme.

There are plans to achieve the following indicators, among others, by 2020:
  1. the share of domestic drugs as a proportion of the pharmaceutical market by value should be 50%
  2. the share of medical devices and medical equipment accounted for by domestic manufacturers should be 40%
  3. a sevenfold increase in the share of high-tech products as a proportion of the total production of the pharmaceutical and medical industry in comparison with 2011
  4. an increase in exports of pharmaceuticals and medical products to no less than RUB 105bn
  5. an increase to 50% of the share of organisations engaged in technological innovation in the pharmaceutical and healthcare industry as a proportion of the total number of producers
  6. 90% of the medicines on the VED list should be produced in Russia
  7. 75% of pharmaceutical and 85% of healthcare companies should be modernised.
The aim of the programme is to elevate the Russian innovative pharmaceutical and medical industry to a global level. The programme is to be implemented in two stages: stage I between 2013 and 2015, and stage II between 2016 and 2020. The budget of the programme, along with the federal “Development of the pharmaceutical and medical industry of the Russian Federation for the period until 2020 and beyond” programme is RUB 99.4bn (€2.2bn), almost RUB 9bn (€195m) less than that of the previous incarnation of the programme.

Source: PMR
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