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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Coherus BioSciences aims to have four biosimilars on the market by 2023, including ranibizumab and bevacizumab for which it has provided updated timelines for planned US Food and Drug Administration filings.
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Formycon has announced a change of strategy for the FYB201 biosimilar ranibizumab candidate being developed with Bioeq. Both firms insist the change is “not expected to have any impact on the timing of the anticipated launch of FYB201 in the US and EU countries.”