No finished road for U.S. copycat biologics

Patients, health insurers and others anxious for a new road to U.S. approval for cheaper biologic drugs may instead get a traffic nightmare.

"We're never going to be able to post a sign that says 'road finished' because the science is going to evolve," Food and Drug Administration Commissioner Margaret Hamburg told the Reuters Health Summit in New York.

"It's going to be a dynamic process ... it will never be 'done.'"

FDA must create a way to review copycat biologic drugs under the healthcare law passed earlier this year. Proponents have said the move will spur substantial saving for drugs that can cost patients tens of thousands of dollars a year.

Already approved in Europe and other countries, biosimilars can cost 15 percent to 30 percent less.

But some generic drugmakers say they will avoid the new pathway no matter how it turns out and instead seek approval as a brand name biologic, which offers greater protections.

Could FDA handle more traffic on the traditional biologic review front?

"We're trying to work through that. Obviously there are issues of overlapping resources," she said.

FDA kicked off its work to construct the approval process with a two-day meeting last week with a variety of drugmakers, industry groups and patient advocates.

"Now we're really going to have to start building up the program," Hamburg said, although she declined to say when the road ahead could emerge.

"We're at the beginning of this journey."

(Reporting by Susan Heavey. Editing by Robert MacMillan)