German biosimilars developer Formycon AG has submitted a marketing authorization application for FYB203, its Eylea (aflibercept) biosimilar candidate, to the European Medicines Agency. The application has been submitted in partnership with Klinge Biopharma, the exclusive owner of the global commercialization rights for FYB203.
Formycon CEO Stefan Glombitza said: “We are very pleased that with FYB203 we have filed our second biosimilar candidate in the ophthalmology space” – after ranibizumab – “that is likely to become even
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