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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

Biosimilar sponsors want the ability to discuss some patent issues with the US Food and Drug Administration without the transcribers or note-takers present in order to help speed labeling discussions.

Scott Lassman, principal of Lassman Law and Policy, said during the recent Association for Accessible Medicines' GRx Biosims conference that sponsors may not want to discuss patent issues associated with a

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