Originally published 01:31 p.m., June 18, 2007, updated 12:00 a.m., June 18, 2007
Manufacturers of generic drugs seem finally to have a golden opportunity to enter the huge biological-drug market as patents expire on more than billion of brand-name pharmaceuticals.
However, they have two major hurdles to overcome: Congress must create an approval process for generic versions of the complicated and expensive drugs; and Congress may require price-prohibitive clinical trials if it approves generics.
Unlike chemically derived medications, biologics are made from living cell tissue and are used to treat rare disorders, making them far more expensive than conventional pharmaceuticals and more difficult to replicate. Avastin, a colorectal cancer biological made by Genentech, can cost patients ,500 a month.
An approval process does not exist, based on the premise that the drugs are too complicated to duplicate and thus ensure their safety.