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BsUFA III: Industry Eyes Streamlined Review Of New Indications, Phased Review Process

Executive Summary

Janssen and Amgen suggest user fee agreement changes aimed at speeding review process for some biosimilar applications and supplements in comments to US FDA on biologic product competition and innovation, while Merck presses agency to clarify its current view on cross-product labeling.

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New Supplement Timelines, Categories Proposed For BsUFA III

The ideas could potentially address sponsor concerns about the effects of slow reviews.

BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?

Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.

US Biosimilar Sponsors Seek Off-The-Record Discussions

Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions without written record; negotiations for BsUFA III may be opportunity to create such a process.

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