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Swift generic biologics approval unlikely

Pharma Compliance Alert, December 6, 2006

There's little probability of action next year in the 110th Congress that would support approvals of generic biologics. This is good news for bio companies that want to control their intellectual property, because a law that would spur generic biological approvals hurts companies such as Amgen and Genentech.

Currently, their products can't be genericized, because the law won't allow it. The generic industry is expected to make the generic biological issue a topic in upcoming discussions about the Prescription Drug User Fee Act. But Stephen Northrup, health policy director for the Senate Committee on Health Education and Labor, says it may not be much of a fight, because "there are so few senators, even on the committee, who understand the issue."

"It's unlikely to be resolved in the [the next congressional] session," he said at the AMCP conference this fall. Congress is more likely to undergo a study period first, he added.

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