New drug development

Abstract

“2010 was a bleak year for new drug development”. Thus opens your Editorial1The LancetWhere will new drugs come from?.Lancet. 2011; 377: 97Summary Full Text Full Text PDF PubMed Scopus (20) Google Scholar based on the preliminary number of new marketing authorisations approved by the European Medicines Agency in 2010, which was lower than in 2009. Although we basically agree, we would like to make some clarifications. It is true that 2009 was the most prolific of the European Medicines Agency's era in terms of positive opinions for granting marketing authorisations (107 in 2009, 66 in 2008, and 58 in 2007).2European Medicines AgencyMedicinal products for human use: monthly figures—October 2010.http://www.ema.europa.eu/docs/en_GB/document_library/Report/2010/12/WC500099566.pdfGoogle Scholar However, in this year, more generic and biosimiliar medicinal products received a new marketing approval (43·7% of the total) than in previous years, and multiple marketing authorisations were filed for the same active ingredient and fixed-dose combinations. Therefore any short-term comparison against 2009 could be misleading. We have examined the full cohort of human-use drugs authorised in the European Union by a centralised procedure from 1995 to 2009.3Catalá-López F García-Altés A Álvarez-Martín E Gènova-Maleras R Morant-Ginestar C Does the development of new medicinal products in the European Union address global and regional health concerns?.Popul Health Metr. 2010; 8: 34Crossref PubMed Scopus (22) Google Scholar This 15-year analysis showed that the total number of new authorisations increased over the period analysed. We also highlighted another interesting observation: the ratio between the number of marketing authorisations and the number of active ingredients also increased (figure)—which raises questions about the current extent of the dilemma in pharmaceutical innovation. Instead of focusing on the number of new marketing authorisations, we suggest that it would be more relevant to consider the number of new active ingredients of added therapeutic value that address unmet needs. We believe this needs to be raised when considering the success of new drug development. The opinions expressed in this letter are of the authors and do not necessarily reflect the position or opinion of their institutions. We declare that we have no conflicts of interest.