FDA’s Inaugural Biosimilar Review Bumpier Than First Appeared
Executive Summary
How agency handled issues around protein content differences, statistical analyses of quality data and immunogenicity testing for Sandoz’s Zarxio may prove instructive for future 351(k) applicants.
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Biosimilars Statistical Guidance Reflects Early Development Approach
US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.
Sandoz's Multi-Switch Biosimilar Trials: A View To Interchangeability?
Company's application development seems to be outpacing FDA's policy development in next step along the 351(k) pathway.