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

2024-07-01

上市批准生物类似药专利到期引进/卖出

PLANEGG-MARTINSRIED, Germany I June 28, 2024 I 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

About Formycon:

Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. Formycon AG is listed in the Open Market (“Scale”) of the Frankfurt Stock Exchange (ISIN: DE000A1EWVY8 / WKN: A1EWVY).

About Biosimilars:

Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of serious diseases such as cancer, diabetes, rheumatoid arthritis, multiple sclerosis and eye diseases. In the coming years, many of these biotech drugs will lose their patent protection – and by 2025, medications with revenues of approximately USD 100 billion will be off patent. Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product. Currently, global sales of biosimilars are estimated at more than USD 15 billion. By 2030, analysts estimate that this figure could rise to over USD 74 billion.

SOURCE: Formycon

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