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.
Formycon Delay Pushes Back Coherus’ Ranibizumab
FDA Requests Additional Data On Lucentis Rival
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.
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