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With Biosimilar Statistical Guidance Withdrawn, Expect Sponsor-Specific Advice, FDA's Christl Says

 
• By Derrick Gingery

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.

FDA entrance sign 2016

BOSTON – The US FDA expects to give more sponsor-specific advice while its biosimilar guidance on statistical approaches to showing analytical similarity is being rewritten.

Leah Christl, associate director for therapeutic biologics in FDA's Office of New Drugs, told the Pink Sheet in a June...

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