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Formycon Files Aflibercept With US FDA

Klinge And Coherus Are US Partners For FYB203 Biosimilar Rival To Eylea

 
• By Dave Wallace

Formycon has announced the filing of its FYB203 aflibercept biosimilar rival to Eylea in the US. The product is set to be marketed by Coherus once approved.

US flag reflected in eye
Formycon has filed its second ophthalmic biosimilar in the US • Source: Shutterstock

Formycon has submitted its FYB203 proposed biosimilar rival to Eylea (aflibercept) to the US Food and Drug Administration, marking the second public confirmation of a US biosimilar aflibercept filing after Viatris and Biocon announced their own submission in late 2021. (Also see "Viatris Believes Eylea Biosimilar Candidate Is First To Reach US FDA’s Desk" - Generics Bulletin, 10 November, 2021.)

The biologics license application for FYB203 “has been submitted to the FDA in line with the initial schedule,” Formycon said....

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