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US biogenerics approvals “should follow Europe”


Ahead of today’s US Senate committee hearing on legislation to enable the US Food and Drug Administration to back generic versions of biological drugs, Democrat Senator Edward Kennedy has suggested that requirements for approval should follow the cautious European model.

“We have a responsibility to expand the horizons of medical science in every responsible way possible so people can live longer and fuller lives. Our goal in legislation should be to enable companies to invest in new medical breakthroughs while doing all we can to cut costs for patients and protect safety,” said Mr Kennedy, who chairs the Senate Health, Education, Labor and Pensions Committee, which will conduct the hearing.

Meanwhile, members of the Coalition for a Competitive Pharmaceutical Market have been in Washington DC lobbying for legislation to allow an approval pathway for biogenerics and counter the arguments of biotechnology companies that biogenerics might not be as effective as the original branded versions, and could also pose safety problems.

The coalition includes large national employers such as General Motors, plus health insurers, pharmacy benefit managers, pharmacies and generic drug manufacturers. According to chairperson Annette Guarisco, the coalition supports the bipartisan Access to Life-Saving Medicines Act 2007 as “a safe, science-based approach that appropriately leaves full discretion to the FDA to determine the safety and efficacy of biogenerics”.

Former FDA Commissioner Mark McClellan said recently he had always believed it was “an issue of when, not if” Congress passed legislation to create a clear, efficient abbreviated approval pathway for biogenerics. The decision might well come this year, he said.

PharmaTimes 08/03/2007

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