Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study
06 Feb 2023
Phase 3Clinical ResultBiosimilarDrug Approval
MUNICH, Germany I February 06, 2023 I Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) today published positive preliminary efficacy and safety data from MAGELLAN-AMD Phase III clinical trial for FYB203, its proposed biosimilar to Eylea®.
The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea® in patients with neovascular age-related macular degeneration (nAMD).
The primary endpoint of the comparative global Phase III trial measures the change in best corrected visual acuity after eight weeks from baseline. The values obtained for FYB203 and the reference product are within the relevant equivalence limits. In addition, to date, the study was conducted without any clinically relevant differences in terms of safety and immunogenicity.
Following the approval and market launch of the ophthalmological biosimilar for Lucentis® (FYB201 marketed as Ongavia®2 (UK), Ranivisio®3 (EU), and CimerliTM4 (US)), Formycon is now announcing, with FYB203, another successful development in the field of ophthalmology, thereby highlighting its strong position in this area.
Neovascular age-related macular degeneration (nAMD) is caused by the excessive growth of blood vessels in the retina. The active ingredient aflibercept inhibits the vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. In industrialized countries, AMD is the most common cause of severe visual impairment or blindness. According to estimates, up to 77 million Europeans will be affected by 2050.[i]
Eylea® is currently the top-selling drug in the field of age-related eye disease and in 2021 achieved revenues of around US$ 9 billion. Recently, Klinge Biopharma GmbH, licensee and exclusive holder of the worldwide commercialization rights of FYB203, had entered into a binding term sheet for the exclusive commercialization of FYB203 in the United States of America with Coherus BioSciences, Inc.
Formycon’s CSO, Dr. Andreas Seidl, comments on the successful phase III study as follows: “We are delighted that our second project in the field of ophthalmology was able to impress in the clinical phase III MAGELLAN-AMD study. Given the extensive experience from FYB201, we are confident that we will also be able to make a high-quality and cost-effective biosimilar available with FYB203, thereby further expanding our strong position in the field of biosimilar development.”
[i] Li JQ, Welchowski T, Schmid M, et al. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis British Journal of Ophthalmology 2020;104:1077-1084.: https://bjo.bmj.com/content/104/8/1077. Last accessed in January 2023.
1Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc.
2Ongavia® is a registered trademark of Teva Pharmaceutical Industries Ltd.
3Ranivisio® is a registered trademark of Bioeq AG
4CimerliTM is a trademark of Coherus BioSciences, Inc
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. Global sales of biosimilars are estimated to exceed $15 billion by 2020. By 2030, analysts estimate that this figure could rise to over $60 billion.
SOURCE: Formycon
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