Celltrion Is Latest To File Eylea Rival In US

Korean Firm Submits Application For CT-P42 Aflibercept Biosimilar To US FDA

Celltrion has become the latest firm to reveal that it has filed a biosimilar Eylea application with the US FDA in the form of its CT-P42 aflibercept candidate.

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.
Celltrion has submitted its Eylea biosimilar to the FDA • Source: Shutterstock

Celltrion has revealed a filing for a biosimilar version of Eylea (aflibercept) in the US, stating that it has filed its CT-P42 candidate with the US Food and Drug Administration to cover all indications of the original ophthalmic brand, excluding pediatric indications.

The Korean firm said it planned to “proceed sequentially” with filings in other major global markets such as Europe, noting...

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 Biosimilars

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By 

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Dr Reddy’s And Alvotech Team Up On Keytruda Rival

 
• By 

After previously partnering on denosumab, Alvotech and Dr Reddy’s have announced a further alliance to co-develop a biosimilar version of Keytruda (pembrolizumab).

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

UK-EU Deal ‘Must Include Medicines, Not Just Sausages,’ Urges Medicines UK

 

The UK struck three international agreements in May, but two of them failed to include medicines or provide any benefits for the pharmaceutical sector. Medicines UK warned that protecting medicine supplies should be of the same importance as defense.

More from Products

Shilpa Stumbles On Lenvima Challenge And Faces Wait Until 2036

 
• By 

Generic competition to Eisai’s oral-dose blockbuster cancer therapy Lenvima is set to materialize in the US in 2030 – however, for now, that won’t be from ANDA filer Shilpa Medicare.

The Generics Bulletin Podcast: The Global Generics & Biosimilars Awards 2025

 

With entries now open for the Global Generics & Biosimilars Awards 2025 – which takes place in Frankfurt on Wednesday 29 October – Generics Bulletin’s editors discuss all the key details, including tips for entrants, in our latest podcast.

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By 

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now