June 28, 2007 / 1:20 PM / 12 years ago

Path for generic biologics clears Senate panel

WASHINGTON (Reuters) - A U.S. Senate panel voted on Wednesday to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines.

Brand-name manufacturers would receive 12 years of exclusive marketing time before generic competition could start under a bill that cleared the Senate Health, Education, Labor and Pensions Committee by a voice vote.

The House of Representatives has yet to consider a similar bill. Senate supporters hope both chambers can agree on an approach and include it in a broad Food and Drug Administration bill expected to pass in the coming months.

Biologic medicines are derived from living things, and manufacturers say they are much tougher to produce than traditional, chemical-based medicines.

The costs of biotech medicines often reach tens of thousands of dollars per patient each year. They treat a range of diseases including cancer, multiple sclerosis and rheumatoid arthritis.

Generic competition could save patients and taxpayers billions of dollars, said committee chairman Edward Kennedy.

“The bill reflects a balanced approach that enables patients to have safe, effective and affordable biological drugs, while preserving the incentives that have brought these life-saving advances to the American public,” he said.

Kennedy, a Massachusetts Democrat, wrote the bill with Democrat Hillary Clinton of New York and Republicans Mike Enzi of Wyoming and Orrin Hatch of Utah. The senators said both sides had compromised, particularly on setting brand-name exclusivity at 12 years.

Sen. Sherrod Brown, an Ohio Democrat, said the period was excessive. He offered but withdrew an amendment to cut it to seven years.

If the measure becomes law, several biotech drugs could be open to generic competition because their patents have expired and they have been sold for at least 12 years, Senate staff said.

They include Amgen Inc.’s anemia drug Epogen and Johnson & Johnson’s rival Procrit, and Biogen Idec’s multiple sclerosis treatment Avonex.

To win FDA approval, a generic company would have to conduct at least one clinical trial to show there were no meaningful differences between its product and the name-brand counterpart. The agency could waive the clinical-trial requirement and rely on animal studies and other data.

The FDA also could designate a copycat version as interchangeable, meaning it could be substituted for the brand-name version.

Generic drugmakers are pushing for a legal pathway for the copycat drugs but said the 12-year exclusivity for name brands was too long.

“Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice,” Kathleen Jaeger, president of the Generic Pharmaceutical Association, said in a statement.

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