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US-Congressman vows to craft bill allowing generic biotech drugs
Posted by: Prof. Dr. M. Raupp (IP Logged)
Date: September 21, 2006 09:47AM ; ;

Rep. Henry Waxman (D-Calif.) yesterday promised to introduce legislation
establishing a regulatory framework for approving cheap copies of highly
complex and expensive biotechnology drugs, September 2006 by George E.

The drugs, known as biopharmaceuticals or biologics, include the latest
cancer treatments, which can cost up to $30,000 per month. They are produced
in high-tech laboratories under conditions that are so difficult to
reproduce that the Food and Drug Administration does not yet have a process
for approving generic copies of biologics.

"Patients who need these drugs pay tens of thousands of dollars," Waxman
said during a speech to the Generic Pharmaceutical Association's annual
policy convention. "Can you imagine paying for them if you have no health

"We have to do something to get generic biologics on the market as soon as

Biotech drugs, a potentially im portant new source of revenue for generic
drugmakers, is at the top of the trade group's two-day agenda.

For the $61 billion generic drug industry, the stakes are huge. Sandoz, Teva
Pharmaceutical In dustries and Barr Laboratories of Woodcliff Lake, N.J.,
are investing heavily to acquire the scientific know-how to make biotech
drugs, and they are looking to capitalize on impatience by insurance
companies and patients for cheaper alternatives.

Since August, governors of seven states -- Kansas, Minnesota, Vermont,
Wisconsin, New Mexico, Virginia and West Virginia -- have petitioned the FDA
to release long- delayed guidelines for approving the simplest biotech
drugs, insulin and human growth hormone.

"We will face an uphill climb," said Waxman, co-author of legislation
enacted in 1984 that paved the way for generic drugs. "Clearly, brand-name
companies are doing anything and everything to hold on to market in the face
of stiff generic competition."

Biologics represent the fastest- growing segment of the nation's $259
billion drug market. Last year, sales rose 17 percent, to $27.5 billion. By
2010, Wall Street analysts predict sales could reach $60 billion, and as
many as 50 new biolog ics could hit the market. Also by that time, more than
$10 billion worth of biotech drugs will lose patent protection, opening the
door to generic competition.

But no regulatory system cur rently exists in the United States for
approving substitute versions of biotechnology drugs, the result of a highly
complex process that involves genetically engineered cells grown in a

The European medicines agency and regulators in Mexico and Australia allow
generic compa nies to produce and sell biophar maceuticals.

Big brand-name drugmakers such as Pfizer, Schering-Plough and Johnson &
Johnson argue the FDA should proceed with caution. Biologics are large,
complex molecules produced by living organisms, and the manufacturing
process cannot be duplicated.

They argue generic drugmakers should be required to take their drugs through
clinical trials to establish their safety and efficacy, just as the
brand-name companies have done.

Generic drugmakers counter that scientific testing methods have advanced to
the point that the FDA should judge copycat biologics on a case-by-case

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