Formycon and Klinge Apply for EU Approval of FYB203, Biosimilar to Regeneron’s Eylea® (aflibercept)

Formycon AG and Klinge Biopharma GmbH announced that they have applied to the European Medicines Agency (EMA) for marketing authorisation in the EU for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

Only a few days before on 24 November 2023, Celltrion announced it also applied for EU approval of its aflibercept biosimilar CT-P43.  On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.