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Formycon Delay Pushes Back Coherus’ Ranibizumab

FDA Requests Additional Data On Lucentis Rival

 
• By Dave Wallace

Formycon and Bioeq’s US filing for a biosimilar ranibizumab rival to Lucentis has been delayed after the FDA requested further data following a manufacturing change. Rights to the biosimilar have been licensed exclusively to Coherus in the US.

Delayed
Formycon and Bioeq's US Ranibizumab Application Has Been Delayed • Source: Shutterstock

Formycon has announced that its US filing for its FYB201 ranibizumab biosimilar has been delayed by several months, after the US Food and Drug Administration asked the firm and its licensing partner Bioeq for more information on the application following a manufacturing change.

Coherus BioSciences had recently struck a deal to acquire exclusive rights from Bioeq to commercialize the biosimilar rival to Lucentis in the US, with Coherus planning to launch the product in 2021. (Also see "Coherus Will Launch US Lucentis Biosimilar By 2021" - Generics Bulletin, 14 November, 2019

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