Biologics are twice as successful as novel small-molecule drugs in gaining market approval, according to a new study. At the 13th Annual Biotechnology Industry Organization (BIO) CEO and Investor Conference, BIO and BioMedTracker, of San Diego, presented their analyses of the approval rates of 4,275 drugs in development from 2003 to 2010. They found that drug success rates from phase 1 to approval was 9% for all indications. Overall rates for secondary indications rates were lower: 14.5% for lead indications and 3.2% for secondary. A further analysis of the types of drugs achieving approval showed that biologics were almost twice as likely as new molecular entities (NMEs) to get approved for a lead indication (26% and 14% respectively). Notably, over 85% of the NMEs are small-molecule drugs. In addition, “The biologics do not include vaccines,” says Michael Hay, senior biotechnology analyst at BioMedTracker, who listed the biologics included in the data set as bacterial products, cellular therapies, monoclonal antibodies, natural and synthetic proteins, nonviral gene therapies, viral gene therapies, peptides and polyclonal antibodies. Hay also observed that, “Monoclonal antibodies make up over half of the biologic drugs in the data set.” Worth noting, non-NMEs were most likely to get approved for any indication (lead or secondary, 41% and 10%, respectively), suggesting that developers of follow-on products benefit from the experience of drug developers who forge the first regulatory pathway for a new drug class.