1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

Amgen Confirms US Aflibercept Filing As Regeneron Awaits Biocon Trial Fate

Key Exclusivity In May 2024, But Feeling Is That H2 2025 Launch More Likely

 
• By Dean Rudge

Amgen has thrown its hat in the ring to launch a US biosimilar to Regeneron’s Eylea eye-disease blockbuster, as all eyes remain on the outcome of a key patent-infringement trial between Biocon and the originator.

perfect blue eye macro in a sterile environment and perfect vision in resolution 6k, concept, the vision of the future and healthy life concept. view precise and straight to the target.
• Source: Shutterstock

As the clock ticks closer potentially on one of the largest biologic opportunities in the US in the current decade, Amgen has confirmed that the US Food and Drug Administration has accepted for filing its ABP 938 proposed biosimilar to Eylea (aflibercept) 2mg.

The California-based biotech had earlier unveiled positive results from its Phase III comparison trial for ABP 938 in patients with

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
Start Free Trial

Already a subscriber?

More from Biosimilars

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

 
• By Urtė Fultinavičiūtė

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.

Generics Bulletin Explains: The Landscape For Denosumab Biosimilar Competition

 
• By Dave Wallace

One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

 
• By Dean Rudge

Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.

More from Products

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By Dave Wallace

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Amgen Biosimilars Continue Surge Ahead Of Imminent Denosumab Competition

 
• By Dean Rudge

Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.