Browsing by Author "Räsänen, Pirjo"

A notable amount of the R&D resources of the proprietary drug firms seems to be directed towards the improvement of existing drugs. Hypothetically, this may lead to interesting formulation development strategies. The purpose of the study was to find out, whether any trends in pharmaceutical product development could be detected from data on granted marketing authorisations. Also the lifecycle management approaches the major pharmaceutical companies use to protect their blockbuster products from generic competition and to ensure their market share were in the interest of this study. The emphasis of the study was on oral solid dosage forms. A combination of qualitative and quantitative methods was employed to obtain a wide view on the subject of the study. Qualitative interviews with the Finnish regulatory authorities were used to collect background information for the quantitative part, which consisted of the marketing authorisation databases covering all MA procedures in Finland, the centralised procedure in the EU, and world's ten major pharmaceutical companies in the US. Based on the study results, there was a remarkable rise in the proportion of generic products of all MAAs authorised in Finland and through the centralised procedure within the European Union during 2000-2010. This change may be at least partly amounted to the legislative changes creating incentives for the use and the manufacture of generic drug products, such as the generic substitution and the reference pricing systems. The US data showed the inclination of the big pharma towards lifecycle management: the majority of the new MAs granted to the world's ten major pharmaceutical companies in 2005-2010 were for this purpose. The ratio of lifecycle management to new molecular entities was almost 4:1. Solid oral dosage form is undeniably the most popular method of drug administration, which was confirmed by the expert interviews and the marketing authorisation data as well. The role of oral solids was even more pronounced within the generic MAs. When innovation was measured by the proportion of non-conventional dosage forms, the US data on solid oral dosage forms indicated strong innovation compared to the Finnish or EU data. This may reflect the innovative product portfolio of the major pharmaceutical companies. The proportion of non-conventional oral solid dosage forms was remarkably smaller in generic than in reference products across all regions. In lifecycle management, the most commonly used strategies were new formulation, new strength or new combination of an existing product. Within the solid oral dosage forms, two-thirds of the new LCM formulations were modified-release preparations. Lifecycle management is an essential part of the major pharmaceutical companies' business strategy, the importance of which was illustrated by the case study of Coreg tablets.