Generic biologicals blocked by lack of federal approval process

The FDA is working on a policy, and a new bill would create an approval mechanism.

By Doug Trapp, AMNews staff. Nov. 13, 2006.

Washington -- Generic human growth hormone is already available in Europe and Australia, but Americans are facing an undetermined wait for this and other cheaper biopharmaceuticals.

So far, there is no Food and Drug Administration policy for approving generic biologicals, often called "follow-ons" in the United States and "bio-similars" in Europe.

The FDA has been formally working on a policy for about a year, but it won't be finished imminently, said FDA spokeswoman Crystal Rice. The agency had no other comment.

A bill introduced in September by Rep. Henry Waxman (D, Calif.) would establish a method for the FDA to approve generic biological drugs.

The measure, the Access to Life-Saving Medicine Act, is in response to the booming market for biological drugs and their high costs. Waxman will reintroduce the legislation next year if it doesn't pass this year, his staff said.

In 2005, sales of biologicals increased 17% to $32.8 billion, according to IMS Health, a company that tracks pharmaceutical sales. That number is expected to increase to between $60 billion and $90 billion by 2010, according to various estimates.

The FDA has approved more than 254 brand-name biological medicines for the treatment of cancer, arthritis, anemia and other diseases.

More than 300 biological drugs and vaccines are in clinical trials. Among the conditions they would treat are heart disease, Alzheimer's disease, diabetes, AIDS and multiple sclerosis, according to the Biotechnology Industry Organization, which represents more than 1,100 drugmakers and related groups in the United States and 31 other countries.