Formycon and Celltrion Announce FDA Submission of aBLAs Seeking Approval to Market Aflibercept Biosimilars

On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates.  Formycon and Celltrion are the second and third biosimilar developers to announce submissions of aflibercept aBLAs, following Viatris Inc.’s submission in October 2021.  As we have previously reported, Biocon Biologics Ltd. now owns the rights to Viatris’s aflibercept biosimilar.

Formycon and its licensing partner, Klinge Biopharma GmbH (“Klinge”), announced Thursday, June 29, 2023 that an aBLA for FYB203, a biosimilar candidate for Eylea® (aflibercept), had been submitted to the FDA and that a decision on acceptance is expected within 60 days.  As we previously reported, Coherus BioSciences Inc. agreed in January to acquire the exclusive commercialization rights to FYB203 from Klinge.  And per our prior reports, Formycon conducted its Phase III trial of FYB203 in neovascular age-related macular degeneration (AMD).

Celltrion announced today, June 30, 2023 that it has submitted an aBLA seeking approval to market its aflibercept biosimilar candidate, CT-P42, for the full range of non-pediatric approved indications of Eylea®.  Celltrion indicated that submissions to regulatory authorities in Europe and other major economies are forthcoming.  As we previously reported, Celltrion conducted its Phase III trial of CT-P42 in diabetic macular edema (DME).