US appros of biotech drugs nearly doubled in last decade, says Tufts CSDD

US regulatory approvals for new biopharmaceuticals nearly doubled in the last decade, compared to the 1990s, according to the Tufts Center for the Study of Drug Development, but drug developers "face substantial challenges" if they are to maintain that pace, the study's author says.

During the 2000-09 period, 65 biopharmaceutical products received marketing approval from the Food and Drug Administration, up from 39 in the 1990s and 13 in the 1980s, according to a recently completed Tufts CSDD study.

Challenges ahead