By Lisa Richwine
WASHINGTON (Reuters) - A key U.S. lawmaker said on Thursday he had not yet seen a workable approach to creating an approval pathway for generic versions of expensive biotechnology medicines.
House Energy and Commerce Committee Chairman John Dingell said in an interview he was working on the issue but was not ready to embrace any of the various legislative proposals on the medicines, also called biologics.
"There are a lot of people running around here saying they've got a solution to the problem. I'm not satisfied that's so," Dingell said in an interview for the Reuters Regulation Summit.
"Nobody has told me yet that they have something that would really satisfy me as to, first of all, protecting the consumer and assuring that in fact this was identical with the way (the brand-name drug) worked in the body," the Michigan Democrat added.
The Republican administration of President George W. Bush surprised many by calling on Monday for legislation enabling the FDA to approve generic biologics, which are made from proteins from living cells.
Copycat versions could provide big savings for insurers and patients -- some of whom pay thousands of dollars for branded biotech drugs, which are typically injected because they involve large proteins that are destroyed by the stomach.
The medicines treat conditions like anemia, rheumatoid arthritis, hepatitis and cancer.
Generic companies such as Barr Pharmaceuticals Inc, Hospira Inc and Teva Pharmaceutical Industries Ltd are pushing for legislation the Food and Drug Administration says it needs to approve the drugs in the United States. Continued...
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