FDA Commissioner Andrew von Eschenbach on Thursday told pharmaceutical company officials that the agency likely would consider generic versions of biotechnology medications "similar" to, but not interchangeable with, brand-name versions, the AP/Miami Herald reports. At the annual meeting of the Pharmaceutical Research and Manufacturers of America, von Eschenbach said, "We recognize that the end point would be what could be best described as similarity. Similarity in the sense that when a doctor gives you the product -- delivered it to a patient -- it will achieve an effect that is similar to the effect that we expected from the innovative ... compound." Biotech medications, which are comprised of proteins from living cells, are more expensive and complex to manufacture than traditional chemical treatments. As a result, officials for FDA and brand-name pharmaceutical companies have raised concerns about the ability of the agency to ensure the safety and effectiveness of generic versions of biotech medications. FDA officials also have said that the agency lacks the legal authority and scientific guidelines required to approve generic versions of biotech medications. However, the Generic Pharmaceutical Association has said that FDA currently has the ability to approve generic versions of biotech medications. Kathleen Jaeger, president and CEO of GPhA, said, "The commissioner is acknowledging that when brands make changes to their products, they are no longer identical to the approved product, but FDA follows sound science to review and approve these changes. This same sound science will be used to review biogenerics for safety and efficacy" (Bridges, AP/Miami Herald, 3/15).

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