Thursday, June 28, 2007

Path for generic biologics clears Senate panel

As I noted in my post on Tuesday when I said a vote could come as early as this week, yesterday, the Senate panel voted to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines. I believe the 12-year period of marketing exclusivity seemed excessive. Fortunately, generic insulins including analogs now covered by patent protection, are considered by the FDA to be small-molecule drugs and are therefore only entitled to 7 years exclusivity protection. What this bill does, however, is eliminates any excuses the FDA may have and outlines clear procedures for generics, thus increasing the liklihood that generic versions of regular and NPH insulin could soon emerge from companies including Teva, Novartis (through its Sandoz generics unit), Barr, Dr. Reddy's and others. For my full analysis of the possibility for generic insulin, you may download a copy of my article here.

In spite of my concerns about the revisions that were made, I am still pleased this legislation was voted on, as it increases the likelihood that this could become law in 2007. The bill now must go through the House, and when their respective bills are reconciled, there is still an opportunity to express your concerns to your House representatives about this, thus increasing the chance that the exclusivity period could be reduced when the Senate and House versions of the bill are reconciled.

Path for generic biologics clears Senate panel
By Lisa Richwine, Reuters
Thu Jun 28, 2007 9:18AM EDT

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.

© Reuters 2007. All rights reserved.

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The story was also covered by Bloomberg, which addresses some items the Reuters story didn't. See the Bloomberg story here.

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