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Consumer Watchdog Opposes Safety Testing
In an irony-laden move, Consumers Union is opposing mandatory clinical safety and efficacy testing of advanced pharmaceutical products known as follow-on biologics (FOBs). CU, which usually favors expanded regulation of the pharmaceutical industry, has told Congress that clinical trials for FOBs "‘should be the exception and not the rule,’ and only be required in special circumstances at the discretion of the FDA."

Biologics are therapeutic substances "manufactured from living cells or organisms by programming a cell line to produce a desired protein in a highly controlled environment." FOBs, also known as "biosimilar" substances, are attempts to manufacturer drugs which are comparable to the original pharmaceutical that has undergone extensive clinical testing prior to FDA approval.

Amgen informed Congress that, due to the "innate complexity of biologics" and because FOBs do not use the original cell or manufacturing process, there will there will inevitably be "differences between the structures of the biosimilar and the innovator product that could have significant clinical implications for patients. A biosimilar product could be more or less potent...or it could cause an immune response...not seen with the innovator product." Thus, because "it is not possible to predict the clinical consequences of such differences, it is necessary to conduct clinical studies...." The company notes that clinical testing of FOBs is required in Europe.

Promoting patient access to biologics is an important Congressional goal. In doing so, however, as the biotechnology industry association stated, legislators should not require patients "to accept greater risks or uncertainties...." CU should not be promoting untested risks to patient health.

See Bioworld article

See Congressional docket of responses

See BIO FOB website

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