Biopharmaceuticals "need fewer studies"

New biopharmaceutical products require fewer clinical studies and farfewer human subjects than pharmaceuticals before they receive US or European approval, according to a new study from the US Tufts Center for the Study of Drug Development.

New biopharmaceuticals averaged 11.8 clinical studies during 1994-2000, compared with an average of 37 for pharmaceuticals, it estimates. During the same period, an average of 1,014 human subjects were studied for each biopharmaceutical application approved, compared with 4,478 subjects for each new pharmaceutical product.

One reason for this may be to do with the fact that many biopharmaceutical products are developed to treat diseases with small patient populations and/or which are serious or life-threatening, according to the study. It found that orphan drugs required the smallest number of Phase I studies, averaging only three per product.