Biosimilar sponsors using reference products licensed outside the U.S. will need bridging data that is likely to include pharmacokinetic data from the biosimilar product, the U.S.-licensed reference product, and the non-U.S. licensed product, FDA says in a new biosimilars draft guidance.
The draft guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,” is intended...
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