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Biosimilar User Fee Agreement Puts FDA On Hook For Delayed Guidances

 
• By Sue Sutter

Draft guidelines on interchangeability and statistical considerations due by end of 2017, suggesting long-awaited documents may not see the light of day this year as many had hoped.

The FDA-industry agreement on the next-generation Biosimilar User Fee Act (BsUFA) program includes target dates for long-awaited agency guidance documents on biosimilar development.

However, this may be best viewed as a schedule without certainty, as industry seems likely to remain in limbo on key issues such as interchangeability, naming and labeling for the

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