Jean-Louis Prugnaud
Jean-Hugues Trouvin
Editors

2013

Biological medicinal products including biotechnology-derived medicinal products (often referred to as ‘‘biologicals’’) have an impressive record in treating numerous serious diseases, and their market is growing faster than that of all pharmaceuticals combined. Insulin produced by using recombinant DNA technology was the first approved therapeutic protein. It entered the US market in October 1982 and subsequently also gained its marketing authorisation in Europe. Since that time, which created, a ‘‘gold rush mood’’ of sorts, the progress in the research and development of these innovative medicinal products has accelerated significantly.