Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA)
- Category: Antibodies
- Published on Friday, 30 June 2023 10:20
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MUNICH, Germany I June 29, 2023 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge“) announce that the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea®1 (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration („FDA“) in line with the initial schedule. Within 60 days after submission, FDA is expected to decide on whether to accept and to further review the BLA (“file acceptance”).
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.
“We are very delighted to bring our second biosimilar candidate in ophthalmology on formal track for approval in the U.S. I would like to thank our licensing partner Klinge for their continuous support as well as the entire Formycon Team for their great efforts. With FYB203 we are going to address an important as well as growing market for the treatment of severe retinal diseases and contribute to alternative and cost-effective therapeutic options,” says Formycon CEO Dr. Stefan Glombitza.
“The submission of the BLA for FYB203 is proceeding according to our initial planning and we have once again demonstrated the agility and expertise of our development organization. FYB203 is an excellent complement to our ophthalmic portfolio and in addition to our already approved ranibizumab biosimilar (FYB201), we are fully committed in making another highly effective treatment option available,” comments Formycon CSO Dr. Andreas Seidl.
Eylea® is a registered Trademark of Regeneron Pharmaceuticals Inc.
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.
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.