Formycon announces File Acceptance for FYB203, a biosimilar candidate to Eylea® (aflibercept), by the U.S. Food and Drug Administration (FDA)

2023-08-29

上市批准

MUNICH, Germany I August 29, 2023 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the U.S. Food and Drug Administration (“FDA”) has accepted the biologics license application (“BLA”) for FYB203, a biosimilar candidate to Eylea® (Active Ingredient: aflibercept), for review (“File Acceptance”). The agency assigned a target action date of June 2024.

Eylea® is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. It inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina. With global sales of around US$ 9.6 billion[i] Eylea® is currently the top-selling drug in this therapeutic area.

“The file acceptance by the FDA is another important milestone to bring our second biosimilar candidate in ophthalmology on track for approval in the U.S. FYB203 is an excellent complement to our ophthalmic portfolio and addresses an important as well as growing market for the treatment of severe retinal diseases,” says Formycon CEO Dr. Stefan Glombitza

Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.

[i]Regeneron Reports Fourth Quarter and Full Year 2022 Financial and Operating Results | Regeneron Pharmaceuticals Inc.0

About Formycon:

Formycon is a leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. The company focuses on treatments in ophthalmology, immunology and on other key chronic diseases, covering the entire value chain from technical development to the clinical phase III as well as the preparation of dossiers for marketing approval. With its biosimilars, Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines. Formycon currently has six biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of a COVID-19 drug FYB207.

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 $15 billion. By 2030, analysts estimate that this figure could rise to over $74 billion.

SOURCE: Formycon

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