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New final FDA guidance begins to clear path for more biosimilars
As 2016 drew to a close, the Food and Drug Administration gave a gift of sorts to drug makers looking to submit to the agency an application for approval of a biosimilar drug when it issued its final guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”
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The finalized guidance follows the draft guidance the agency issued in May 2014.