[CarolynS]

Firms Push for Biotech Generics

Wall Street Journal, JANUARY 26, 2011

A battle is heating up over the meaning of a single word in the health overhaul that could mean billions of dollars to the makers of biotechnology drugs.

The word is "exclusivity." Last year's health law says brand-name makers of the blockbuster medicines are entitled to 12 years of it. The question is whether makers of generics have to wait the whole period before even beginning to seek approval—or can get a head start with regulators so their copies can hit the shelves as soon as the 12 years are up.

Companies including pharmacy network CVS Caremark Corp. and insurer Aetna Inc. want to get their hands on the cheaper generics as soon as possible, and they're calling on the Food and Drug Administration to interpret the law in a way favorable to generic-drug makers.

Biotech medicines, or "biologics," are derived from proteins and used to treat cancer, rheumatoid arthritis and other diseases. Some cost tens of thousands of dollars a year per patient, adding a big cost burden for insurers, Medicare and others who pay for the drugs.

The health-law provision, years in the making, for the first time creates a path to approval in the U.S. for less-expensive generic biologics.

This week three Democratic senators and Republican Sen. John McCain of Arizona came to the generic drug makers' aid.