Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate
May 1, 2007
The push is on to establish an approval pathway for generic versions of biotech therapies. The Hatch-Waxman Act of 1984 established a process whereby generic-drug manufacturers could obtain approval for a product based on the innovator company's data. But Hatch-Waxman doesn't apply to biologics regulated by the Public Health Service Act, and generics makers—as well as some Big Pharma companies and small biotech firms—want Congress to give the Food and Drug Administration authority to set up a similar process for these products as well.