Cheap, Generic 'Biologics' on the Way?
Congress Considers Allowing Companies to Make Low-Cost Copies of Drugs Like Insulin
Complex as a 'Skyscraper'
A bill introduced last month would give the FDA the power for fast-track
approval of generic biologics on a case-by-case basis, as long as companies can
show they are essentially equivalent to the brand-name parent.
"The science supports an abbreviated pathway for [generic]
biologics," said Sen. Hillary Rodham Clinton, D-N.Y., one of several
sponsors of the bill. "We are finally at a place where we are debating how,
Meanwhile, several key Republicans said the bill does not do enough to
ensure the safety and effectiveness of highly complex biologic drugs.
Wyoming Sen. Mike Enzi, the senior Republican on the Senate Health,
Education, Labor, and Pensions Committee, said if traditional drugs are as
complex as a house, biologics were more akin to "a skyscraper."
"One girder out of place could cause the entire structure to fall,"