FDA Urged to Keep Distinctions Between Biologics and Copies
By Mari Serebrov
Washington Editor
Washington Editor
Tuesday, June 18, 2013
Biologics are innovative drugs, biosimilars are copies, and never the twain shall meet. That's the underlying message brand drugmakers sent to the FDA as they urged it to maintain the distinctions between the 351(a) and 351(k) approval paths.
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