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With Biosimilar Statistical Guidance Withdrawn, Expect Sponsor-Specific Advice, FDA's Christl Says

Executive Summary

US FDA's biosimilar chief tells Pink Sheet that sponsors will receive more advice specific to their development programs based on their data package, a practice already in use in some cases.

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Industry May Like FDA's Biosimilar Guidance Withdrawal, But Not The New Information Vacuum

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US FDA's Biosimilars Program: Five Years In, Complete Response Letters Still Outnumber Approvals

Agency is meeting its review timelines for biosimilar applications but handing our more complete response letters than first-cycle approvals; sponsors have publicly disclosed 24 original biosimilar application submissions to the agency since the review program began in fiscal year 2013, with 10 product approvals to date and at least 13 CRLs, according to the Pink Sheet's biosimilars report card.

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US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking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.


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