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DewDiligence

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DewDiligence

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Saturday, 06/23/2007 2:34:46 AM

Saturday, June 23, 2007 2:34:46 AM

Post# of 252486
Senators Agree on Plan for Biogeneric Drugs

[The Senate proposal includes 12 years of marketing exclusivity for branded biopharmaceuticals but allows for substitutable generic versions of the branded drugs upon expiration of the exclusivity period. Whether clinical trials are needed to establish equivalence to the branded drug is left to the discretion of the FDA.

The House has not yet approved a comparable bill, so it’s anyone’s guess what provisions will end up in a compromise between the two chambers.]

http://online.wsj.com/article/SB118251862394944811.html

>>
By ANNA WILDE MATHEWS and VAL BRICKATES KENNEDY
June 23, 2007

A key group of senators reached a deal over how to create a legal pathway for approving generic versions of biotechnology drugs, a breakthrough that increases the chances that a bill might become law this year.

The agreement, among Democratic Sens. Edward Kennedy of Massachusetts and Hillary Clinton of New York and Republicans Michael Enzi of Wyoming and Orrin Hatch of Utah, is important because the four senators represent a broad political spectrum. The next step would be a vote from the full Senate health committee, likely this coming week.

In crafting a draft bill to allow for what they call "biosimilars," or copycat versions of biotech drugs, the four lawmakers agreed to provisions important to both the generic and the biotech industries.

A landmark 1984 U.S. law that created the modern pathway for the Food and Drug Administration to approve generic drugs left out almost all biotech products. Now biotech drugs represent some of the most expensive and important medications, and some of their earliest patents are beginning to expire. Making copies of biotech drugs is harder than with older chemically derived medicines, because they come from living cells.

Sen. Kennedy pledged to try to integrate generic-biotech language into a major FDA bill that passed the Senate last month. That legislation has to become law this year in order to renew funding for the agency. However, the House hasn't yet advanced any generic-biotech legislation, leaving it unclear whether any Senate language would survive a House and Senate conference.

The new agreement allows for the possibility of "interchangeability," meaning that the generic version of the biotech drug could potentially be automatically substituted for the original branded medicine. This is valuable to generic makers because interchangeability increases the use of their products and largely spares them the cost of marketing.

But for the biotech industry, the draft bill also includes an important boon: a guarantee of four years of exclusive sales before a generic maker can apply to sell a biosimilar, and 12 years before a copycat version of a biotech drug can go on the market.

The draft bill stakes out a middle ground on another issue. Biotech companies argued that Congress should require generics makers to do human studies, while the generics industry pushed for flexibility. The draft says that a biosimilar application must include a clinical study or studies but also gives the FDA the power to waive the requirement. [LOL—they could simply say that the need for clinical trials is left to the discretion of the FDA.]
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