Number of monoclonal antibody products in development continues to increase, says Tufts CSDD

Developers are steadily increasing the number of monoclonal antibody products - known as MAbs - for which they are initiating clinical studies, extending a trend that began in the 1990s, according to the Tufts Center for the Study of Drug Development.

The number of novel MAbs entering clinical study worldwide annually rose from 19 in 1997 to 53 in 2010, peaking at 54 in 2008, continuing a trend dating back to the mid-1990s when about a dozen MAb candidates entered clinical study each year, a recently completed Tufts CSDD analysis found. According to Tufts CSDD, from 1997 through 2010, clinical and the US Food and Drug Administration approval phases for MAb therapeutics averaged 7.2 and 1.0 years, respectively.

Total development and approval times for MAbs compare favorably with small molecule drugs, which require an average of 7.5 years in total to follow the same path, as well as with all biotech products, which require an average of 8 years.