Biosimilar Sponsors Want Off-The-Record Labeling Discussions With US FDA

 
• By Derrick Gingery

Hoping to avoid litigation discovery, sponsors ask FDA for avenue to explain patent issues during labeling discussions written record; negotiations for BsUFA III may be opportunity to create such a process.

IP issues often are part of biosimilar labeling carve-out discussions, and could be used in future patent litigation if on the record, sponsors say. • Source: Shutterstock

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