On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept). As we previously reported, when Formycon submitted its aBLA in June 2023, it became the second biosimilar developer to announce submission of an aBLA for an aflibercept biosimilar, after Mylan’s (now Viatris’s) submission in October 2021 (Mylan has since transferred its rights to the aflibercept biosimilar and aBLA to Biocon Inc.). According to Formycon, FDA assigned a target action date for the aBLA of June 2024.
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