Published Online: Tuesday, May 1, 2007

Representatives of the brand name pharmaceutical industry told Congress that current pending legislation to accelerate the marketing of generic "follow-on"biologics could create a "significant risk"for public safety "due to the significant differences between biologic products from different manufacturers." A key problem, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), is that "follow-on biologics are not identical to innovator biologics."

PhRMA said that its members stand ready to support the establishment of a regulatory pathway for follow-on biologics, but only "if patient safety can be assured and the innovation of future medicines is not compromised."Although generic drug manufacturers are not required to conduct clinical trials to secure FDA marketing approval for their regular "small-molecule"generic pharmaceuticals, such studies should be required before generic biologics are approved, PhRMA officials said.

Significantly, however, none of the pending bills addressing follow-on biologics would require such testing. "We believe that unless clinical trials are conducted to show the safety and effectiveness of follow-on biologics? patients would have no assurance that the product they are taking is safe," PhRMA said.

The branded drug group also raised concerns that the pending legislation "would allow a follow-on biologic to be replaced with a similar product—but a product with a potentially different makeup—at pharmacies, hospitals, and physician offices. It is troubling to think that physicians would not know whether their patients are receiving the specific biologic treatment they prescribed, or a similar product that could have very different effects on the patient,"PhRMA said.

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