Formycon Announces EMA Acceptance Of The MAA For FYB203, A Biosimilar Candidate To Eylea (Aflibercept)

Formycon AG and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea¹ (Active Ingredient: Aflibercept), for review.

Aflibercept is used in the treatment of neovascular age-related macular degeneration (“nAMD”) and other severe retinal diseases. Around 67 million people in Europe are affected by AMD^[[i]]. Due to current demographic trends, this number is expected to continue to rise in the coming years. In most cases, intravitreal injections with the VEGF inhibitor Aflibercept can significantly slow down or even stop the loss of vision caused by the neovascular form of AMD.

“The experience of recent years shows that both patients and healthcare systems benefit from biosimilar competition. With the recent EMA acceptance for our ophthalmological biosimilar candidate FYB203, we are an important step closer to providing another effective treatment option – in addition to our already launched biosimilar FYB201 (ranibizumab) – to the many patients affected by severe retinal diseases in Europe”, says Formycon CEO Dr. Stefan Glombitza.

^[i] Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis; Li JQ, Welchowski T, Schmid M, et al. British Journal of Ophthalmology 2020;104:1077-1084. http://dx.doi.org/10.1136/bjophthalmol-2019-314422

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.

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