FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)

Formycon AG / Key word(s): Regulatory Approval
FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb)

28-Jun-2024 / 23:50 CET/CEST
Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News - a service of EQS Group AG.
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Disclosure of inside information according to Article 17 of the Regulation (EU) No 596/2014

FDA grants approval for Eylea^®1) biosimilar FYB203/AHZANTIVE^®2) (aflibercept-mrbb)

Planegg-Martinsried, Germany, 28. June 2024 – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH ("Klinge") announce that the U.S. Food and Drug Administration ("FDA") today approved FYB203/AHZANTIVE^® (aflibercept-mrbb), a biosimilar to Eylea^®.

FYB203/AHZANTIVE^® obtained FDA approval for the treatment of patients with neovascular Age-Related (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO).

The approval for FYB203/AHZANTIVE^® is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. FYB203/AHZANTIVE^® demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Eylea^® in patients with neovascular Age-Related (wet) Macular Degeneration (nAMD).

¹⁾ Eylea^® is a registered Trademark of Regeneron Pharmaceuticals Inc.
²⁾ AHZANTIVE^® is a registered Trademark of Klinge Biopharma GmbH

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

phone +49 (0) 89 – 86 46 67 149 | fax + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com // www.formycon.com

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