Регуляторные исследования и экспертиза лекарственных средств (Feb 2024)

Analysis of Biopharmaceutical Manufacturing Localisation in Russia Considering the Country of Origin of Active Pharmaceutical Ingredients

  • A. A. Khalimova,
  • A. S. Orlov,
  • A. A. Taube

DOI
https://doi.org/10.30895/1991-2919-2024-14-1-53-61
Journal volume & issue
Vol. 14, no. 1
pp. 53 – 61

Abstract

Read online

SCIENTIFIC RELEVANCE. Russia is pursuing a consistent government policy of import substitution and increasing the localisation of pharmaceutical manufacturing. The Strategy for the Development of the Pharmaceutical Industry until 2030 (Pharma-2030) includes the target share of medicinal products from the List of Strategic Medicines that should be fully localised. Since biotechnological medicinal products have high consumption growth rates and are listed as strategic medicines, it is a priority to study their production localisation process.AIM. This study aimed to analyse the degree of biopharmaceutical manufacturing localisation in Russia, considering the country of origin of active pharmaceutical ingredients (APIs).MATERIALS AND METHODS. The study used the State Register of Medicines and sales data of the DSM Group marketing agency. The authors used custom software for the Node.js® platform to determine the degree of production localisation.RESULTS. The analysis showed that the production process was fully localised for 25.6% (in packages) and 26.6% (in roubles) of all biotechnological medicinal products consumed in Russia in 2022. Imported medicinal products dominated the consumption structure, with a share of 33.9% in packages and 31.3% in roubles. Medicinal products with localised secondary packaging accounted for 5.8% in packages and 25.9% in roubles. Finished dosage forms produced using imported APIs had a significant share of 23.7% in packages and 6.2% in roubles. Russian APIs were used to produce 79% of the biotechnological medicinal products listed as strategic medicines, which corresponded to the full localisation of a share of the consumption structure of 10.8% in packages and 32.3% in roubles.CONCLUSIONS. The Russian biotechnological market remains heavily dependent on imported finished medicinal products and APIs. Although the Pharma-2030 target for the production of strategic biotechnological products has been achieved, the quantitative indicators show the necessity to increase output and localisation.

Keywords