1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Biosimilars

The BPCIA Transition: Products, Patents And Exclusivities

 
• By Sue Sutter

Pink Sheet infographic looks at the 95 NDAs moving from regulation as drugs to biologics on 23 March; list includes 27 insulin products, seven of which have unexpired exclusivity that will not carry over when they are delisted from the 'Orange Book.'

March 23, Empty Vintage background.
95 NDAs are headed for a regulatory change on 23 March. • Source: Shutterstock

The US Food and Drug Administration currently estimates 95 new drug applications approved under the Food, Drug and Cosmetic Act will transition to regulation as biologics under the US Public Health Service Act on 23 March.

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

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By Dave Wallace

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.

More from Biosimilars & Generics