What’s Next? Five Things To Look Out For In May

Key US Eylea Exclusivity Comes To A Close; Ireland Weighs Apixaban Appeal

Generics Bulletin previews the most noteworthy and anticipated events for May 2024.

What's Next Image
• Source: Norstella

May is something of a key month for Eylea (aflibercept), one of the largest biosimilar opportunities set to materialize in the current decade. Its US market exclusivity will officially run its course on 17 May, allowing the US Food and Drug Administration to begin approving biosimilars to the multi-billion-dollar treatment for neovascular age-related macular degeneration and diabetic macular edema.

However, rivals are unlikely to reach the market any time soon, as the originator currently has several aflibercept biosimilar sponsors

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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

More from Generics

Tetris Deal Falls Into Place For UK’s Aspire

 
• By 

Niche generics company Aspire Pharma has struck a deal to acquire a portfolio of products from fellow UK firm Tetris Pharma as it is wound up, paying Tetris parent Arecor £0.5m for UK distribution rights and inventory.

US FDA Expands Surprise Foreign Inspections

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By 

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

More from Products