Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and Bioeq GmbH have today announced the launch of the randomized, double-blind, multi-center phase III study for FYB203, a biosimilar candidate to Eylea®. The aim of the clinical study is to demonstrate the comparability of FYB203 and the reference product Eylea® in terms of efficacy, safety and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). Also known as wet AMD, this is one of the main causes of loss of vision in people over the age of 50 in developed countries. The study design was developed in agreement with the US drug authority (FDA), the European regulatory authority (EMA) and the Japanese regulatory authority (PMDA) and is intended to support the approval process in these regions. Bioeq GmbH, a company of the ATHOS Group, is the sponsor of the phase III study.
The active ingredient aflibercept (Eylea®) 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. Eylea® is the highest-selling drug in the field of age-related eye disease and in 2019 achieved revenues of around US$ 7.5 billion. In 2015, Formycon AG concluded an exclusive global licensing agreement for FYB203 with Santo Holding (Deutschland) GmbH.
Formycon’s COO, Dr. Stefan Glombitza, sees the company’s leading position in ophthalmologic biosimilar development being confirmed: “We are delighted that our second project in the field of ophthalmology is now starting the phase III study. Given the extensive experience from the FYB201 project and the successful cooperation with Bioeq GmbH, we are confident that we will also be able to develop a high-quality and cost-effective biosimilar with FYB203. The active ingredient, aflibercept, is an extremely effective and proven treatment for wet macular degeneration and we want to play our part in ensuring that as many patients as possible gain access to this treatment option.”
1 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 four biosimilars in development. Based on its extensive experience in the development of biopharmaceutical drugs, the company is also working on the development of antibody-based COVID-19 compounds.
Bioeq was founded in 2014 and is a leading service provider in the development of biopharmaceutical follow-on products, known as biosimilars. Working with various partners, Bioeq develops third-wave biosimilars and specializes in ophthalmic agents. The development programs meet the standards for highly regulated markets such as Europe, the USA, Canada, or Japan, and are therefore suitable for global licensing. Bioeq’s expertise lies primarily in comprehensive project management, clinical development, the drafting of licensing strategies in dialog with the authorities, the development of application systems for administering the products, the drawing-up of patent strategies, and in license management. Bioeq is currently working on five different biosimilar projects.
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 2020, 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. In 2019, global sales of biosimilars exceeded USD12 billion. Analysts estimate that this figure could rise to around USD 69 billion by 2025.