Why FDA needs track-and-trace for biosimilars

11/21/2012 | Hill, The

The FDA should establish a track-and-trace system to monitor biosimilars, as well as a naming system to distinguish biologics from biosimilars to protect patients, writes Dr. Bert Petersen of the New York University School of Medicine. Tracking can help the health system identify and respond to issues such as the recent meningitis outbreak. Furthermore, doctors must decide the suitable biologic drug for a patient, a decision that can't be overridden by an insurance company or a pharmacist, Petersen writes.

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Hill, The

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