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Biosimilars User Fees Review Pathway

New Supplement Timelines, Categories Proposed For BsUFA III

  • Analysis

Executive Summary

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

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US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement

Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.

Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement

Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.

BsUFA III Negotiations Nearly Done; Commitment Letter Being Written

Supplement approval timeline and regulatory science issues apparently have been resolved.

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