WASHINGTON – Despite a trickle of original applications for new drugs and biologics licenses submitted to the FDA last year, concerns about the drug pipeline drying up may be premature.

A diminishing drug pipeline helped the FDA do a better job of meeting its PDUFA performance goals last year, but the pharmaceutical industry says there's still need for improvement.

WASHINGTON – With biologics one hope of the future, the Obama administration is using its fiscal 2012 budget proposal to pump more competition into the field to bring down the spiraling cost of health care.

WASHINGTON – The Congressional Research Service (CRS) has a few words for those hoping to use the new biosimilar pathway as a shortcut to cash in quickly on the high price of biologics. Be patient. And watch out. This new road could be under construction for a long time.