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The Work-Up

Costly Drugs Known as Biologics

Prompt Exclusivity Debate

July 22, 2009

The New York Times

By ANDREW POLLACK

A bitter Congressional fight over the cost of superexpensive biotechnology drugs has come down to a single, hotly debated number: How many years should makers of those drugs be exempt from generic competition?

But what few people in Washington seem to recognize — or publicly acknowledge, anyway — is that this magic number may ultimately not matter as much as the most vitriolic debaters insist.

At issue are such drugs as Biogen Idec’s Avonex, for multiple sclerosis, which can cost more than $20,000 a year; Genentech’s Avastin for cancer, which can cost more than $50,000; and several Genzyme drugs for rare diseases that can cost $200,000 a year or more. Typically, such drugs are given by injection or intravenous infusions.

These drugs, known as biologics, are complex proteins made in vats of living cells. Because they are hard to copy exactly, they have not been subject to the generic competition that eventually knocks down the price of drugs like Lipitor and Prozac. Pills like Lipitor, known in the industry as small-molecule drugs, are made from simple chemicals whose recipes are easy to reproduce.

[ ... ]

“If your patents are strong, let your patents stand for themselves,” said Katie Huffard, executive director of the Coalition for a Competitive Pharmaceutical Market, a group of employers, insurers, pharmacies and generic makers lobbying for easier access to biosimilars. “That’s what every other industry has to do.”

Costly Drugs Known as Biologics Prompt Exclusivity Debate,
NYT,
22 July 2009,
https://www.nytimes.com/2009/07/22/
business/22biogenerics.html

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