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Biosimilar Development Meetings At US FDA Not Just For Talking Similarity

 
• By Sue Sutter

Sponsors shouldn't wait until pre-submission meetings with the agency to discuss manufacturing, packaging and other matters unrelated to similarity data, FDA's Leah Christl says in remarks seemingly aimed at calling attention to issues that can forestall approval.

Woman listens
US FDA is listening when biosimilar sponsors raise manufacturing and other issues during product development meetings.

User fee-funded product development meetings between the US FDA and biosimilar sponsors are for more than just talking about similarity study issues.

That's the very clear message from Leah Christl, associate director for therapeutic biologics in FDA's Office of New Drugs, as the agency embarks on a new set of product development meeting commitments under the second

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