1. Pink Sheet

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

 
• By Derrick Gingery

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 

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Biosimilars

More from Biosimilars & Generics