FDA chief says biogenerics "similar" not "interchangeable"

The US Food and Drug Administration's Commissioner, Andrew von Eschenbach speaking at the recent annual general meeting of the Pharmaceutical Research and Manufacturers of America (PhRMA), stated the agency's position that generic versions of biotechnology drugs could be considered "similar to" but not "interchangeable with" branded products. Dr von Eschenbach said: "we recognize that the endpoint would be what could best be described as similarity. Similarity in the sense that when a doctor gives you a product it will achieve an effect that is similar to the effect that we expected from the innovative...compound."

In response to the FDA chief's claim, the Generic Pharmaceutical Association (GPhA) argued that the federal agency has the means to approve generic biotechnology drugs. Kathleen Jaeger, the GPhA's president, told the Associated Press: "the Commissioner is acknowledging that when brands make changes to their products, they are no longer identical to the approved product, but [the] FDA follows sound science to review and approve these changes. This same sound science will be used to review biogenerics for safety and efficacy."