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UPDATE 3-Obama urges access to cheaper generic biotech drugs
Thu Feb 26, 2009 6:22pm EST Email | Print | Share| Reprints | Single Page[-] Text [+]
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More Business & Investing News... * Obama seeks cheaper generic biotech medicines

* Administration will prevent deals that block generics

* Savings from generics will go to healthcare reserve fund (Adds Waxman comments, paragraphs 7,15)

By Lisa Richwine

WASHINGTON, Feb 26 (Reuters) - President Barack Obama called for access to cheaper generic versions of biotechnology drugs in a budget plan released on Thursday that seeks savings to pay for a healthcare overhaul.

Copycats of some of the world's most expensive drugs could save taxpayers an estimated $9.2 billion over 10 years and help pay for expanded insurance coverage and improved care, according to budget documents.

Winning a legal pathway for cheaper forms of biotech drugs, or biologics, could open a huge new market for generic drugmakers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) (TEVA.O) and Mylan Inc (MYL.O).

Brand-name companies say they back the idea but want an adequate period of market exclusivity for the original products and safety protections for patients.

Obama's support in his fiscal 2010 spending plan could help move the issue through Congress, which would need to pass legislation to allow U.S. Food and Drug Administration approval of the medicines. Key Democrats support generic biologics but details remain to be worked out.

The Democratic president's push "basically signals the time is now," said Kathleen Jaeger, president of the Generic Pharmaceutical Association, a trade group. "This is really an opportunity to achieve real cost savings."

House Energy and Commerce Committee Chairman Henry Waxman, a Democrat, said legislation to allow FDA approval of generic biologics "is one of my highest priorities this year."

Biologic drugs are man-made forms of human proteins and are more difficult to reproduce than traditional pharmaceuticals. Some biologics cost patients tens of thousands of dollars a year.

The medicines are typically injected and treat conditions ranging from anemia and rheumatoid arthritis to cancer. Examples include Genentech Inc's (DNA.N) Herceptin and Avastin and Amgen Inc's (AMGN.O) Epogen and Aranesp.

Obama's budget outline endorsed the generic industry's position on the amount of market exclusivity that should be awarded for brand-name drugs, Jaeger said. Budget documents backed a period "generally consistent with the principles in the Hatch-Waxman law" for chemical-based drugs.

That law provides five years of exclusivity for new medicines, and three years for new formulations of existing drugs, Jaeger said.

Brand-name companies are pushing for 14 years of data exclusivity, saying that length of time is needed to entice them to develop new treatments. Continued...

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