1. Generics Bulletin
  2. >>Products

Formycon’s US Eylea Biosimilar Is Third In Six Weeks – But Timing Still Uncertain

Originator Regeneron Secures Further Injunctive Relief; Formycon Lodges Appeal

 
• By Dean Rudge

A third US biosimilar to Regeneron’s Eylea has won approval. However, enthusiasm is muted at this stage as biosimilar sponsors, including latest recipient Formycon, continue to battle against court-issued blockades.

Bridge and uncertainty
• Source: Shutterstock

Formycon and its licensing partner Klinge Biopharma have become the third biosimilar sponsors to pick up a US Food and Drug Administration approval for a rival to Regeneron’s Eylea (aflibercept) 2mg in less than two months, with a nod for their Ahzantive (aflibercept-mrbb).

The approval is “another key milestone on our way to becoming the leading pure-play biosimilar developer,” Formycon believes, while helping the company “achieve an outstanding position in ophthalmic biosimilar therapies.”

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 Products

‘Obsessive’ Teva Aims For $800m Biosimilar Sales By 2027

 
• By Dean Rudge

Teva says it is now in the “accelerate growth” phase of its strategic roadmap, with global biosimilar launches set to help the firm achieve its goals.

Trump-Trimmed FDA Finally Releases A Batch Of PSGs – Back To Business As Usual?

 
• By Urtė Fultinavičiūtė

After half a year of silence, the US FDA has published 48 product-specific guidances for generic development. With critical staff laid off, will the health agency stick to its updated PSG publishing schedule?

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

More from Generics Bulletin

Fresenius Adds To Denosumab Competitors In Europe

 
• By Dave Wallace

At a busy meeting of the CHMP, the EMA issued positive opinions for Fresenius Kabi’s denosumab rivals to Prolia and Xgeva, another denosumab biosimilar from Sandoz, a Tecfidera hybrid from Neuraxpharm and a Descovy generic from Viatris. Meanwhile, Ascend has withdrawn a teriparatide filing.

Alvotech And Advanz Add Three More In €160m EU Partnership Expansion

 
• By Dean Rudge

Fresh from filing a proposed biosimilar to Xolair (omalizumab) in the UK, Alvotech and Advanz have shaken hands on a further deal to expand their partnership.

After Dasatinib Apotex Debuts US Tasigna Competition

 
• By Dean Rudge

Canada’s Apotex is continuing to spearhead generic competition in the tyrosine kinase inhibitor (TKI) space for chronic myelogenous leukemia, with the launch of the first generic version of Novartis’ Tasigna (nilotinib) blockbuster.