WASHINGTON - A senior U.S. Democratic lawmaker urged President Barack Obama on Monday to consider what can be done 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 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.
Brand-name drugmakers support legislation that prohibits competition to a biotech medicine for at least 12 years after the original product was licensed for sale. Waxman's bill allows a competitor as soon as five years after approval.
Companies aiming to sell copies of biologics include generic drugmakers such as Teva Pharmaceutical Industries Ltd and Mylan Inc.
Waxman's letter was posted on the committee's website.
(Reporting by Lisa Richwine; Editing by Tim Dobbyn, Gary Hill)