3 March 2020 - In this study, which included 63 of 355 new therapeutic drugs and biologic agents approved by the US FDA between 2009 and 2018, the estimated median capitalised research and development cost per product was $985 million, counting expenditures on failed trials. 

Data were mainly accessible for smaller firms, products in certain therapeutic areas, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018.

This study provides an estimate of research and development costs for new therapeutic agents based on publicly available data; differences from previous studies may reflect the spectrum of products analysed and the restricted availability of data in the public domain.

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