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

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...