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BioWorld - Saturday, February 28, 2026
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» FDA Urged to Keep Distinctions Between Biologics and Copies
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FDA Urged to Keep Distinctions Between Biologics and Copies
June 19, 2013
By
Mari Serebrov
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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