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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...

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