Last year was poor in terms of biotech drug approvals; the Food and Drug Administration (FDA) approved only 6 biologics, down from 16 in 2003 and well below the average of about 12 since 1999. Development times for biologics are also increasing (up to 7 years for 2000–2004), comparable with those for small molecules. On the bright side, standard review time at the FDA has been trimmed down to 2 years over the same period. Drugs tackling cancer, infectious disease and the central nervous system predominate in the biotech pipeline

Credit: No data available for priority approvals in 2004. Source: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
Credit: Source: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
Credit: Source: Tufts Center for the Study of Drug Development
Credit: Source: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
Credit: Source: Biopharm Insight
Credit: By application start year with outcomes by December 2004. Source: European Medicines Agency