US FDA Hearing To Focus On Scientific Standards For Biosimilar, Interchangeable Insulins
Executive Summary
US FDA will use May 13 hearing to gather input about scientific considerations and patient experience as it prepares for the submission and review of biosimilar and interchangeable applications after insulin products transition to biologics in March 2020.
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US FDA assessment of proposed biosimilar and interchangeable insulins in existing delivery forms should be separate from a future determination of whether the products can be safely used as part of a digitally connected treatment system, Lilly says. FDA, AAM representatives suggest this ecosystem approach could become a barrier to access for follow-on products.
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