Biologics Transition 'Dead Zone' Could Be Eliminated Under US Senate Bill

Discussion draft includes provision requiring completion of assessments of transitioning NDA applications filed by 23 September, even if review lasts beyond the official 2020 transition date.

United States Capitol Building in Washington DC USA — Stakeholder comments on the Senate drug pricing discussion draft are due to the Health, Education, Labor and Pensions Committee by 5 June. • Source: Shutterstock

A provision in the draft Senate legislation on drug pricing may help sponsors of upcoming follow-on biologics applications avoid disaster should their assessment not be completed by the 2020 biologics transition.

A new Senate discussion draft would require any applications assessed under Food Drug and Cosmetic Act Section 505 that...