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FDA Offers New Q&A on Biosimilars and Interchangeable Products | Aspen Xchange
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In a recently issued draft questions and answers guidance the US FDA offers insights into how it will handle certain aspects of submissions and labeling for interchangeable biosimilars. When finalized, the FDA will move the questions and answers from the draft guidance to its companion final questions and answers guidance on biosimilar development. In the first of four questions and answers in the draft guidance, the FDA explains how it anticipates handling applications for interchangeable biosimilars that include data to support licensure as a biosimilar but not as an interchangeable product.
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