U.S. lawmaker urges action on generic biotech drugs

WASHINGTON (Reuters) - A senior U.S. Democratic lawmaker urged President Barack Obama on Monday to consider ways to speed access to cheaper versions of biotech medicines ahead of legislation aimed at achieving that goal.

House Energy and Commerce Committee Chairman Henry Waxman, in a letter to Obama, asked his administration "to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics."

Waxman has introduced legislation to create a clear legal path for Food and Drug Administration approval of cheaper copies of biotech medicines, or biologics, which can cost tens of thousands of dollars per year. He said the bill remains "one of my highest priorities this year."

Biologics are man-made forms of human proteins that are tougher to produce than traditional, chemical-based medicines.

The drugs treat conditions ranging from anemia and rheumatoid arthritis to cancer. Examples include Roche Holding AG's Herceptin and Avastin cancer treatments, and Amgen Inc's Epogen and Aranesp anemia therapies.

The FDA in 2006 approved a copycat version of Omnitrope, a human growth hormone made by Novartis AG but said at the time it did not set a precedent for other biologics.

Brand-name makers say they need an adequate period without competition to encourage companies to develop new medicines.

Jim Greenwood, president of the Biotechnology Industry Organization, said his group, which represents brand-name biotech drugmakers, supports legislation that prohibits competition for at least 12 years after the original biotech product was licensed for sale. Waxman's bill allows five years without competitors for original biotech products.

White House spokesman Reid Cherlin said "we look forward to working with" Waxman on the issue and his legislation was consistent with Obama's position outlined earlier this year in his budget proposal.