Munich – Formycon AG, Munich, and bioeq GmbH, Holzkirchen, today announced that they have enrolled the first patient in their clinical Phase III study involving FYB201, Formycon’s biosimilar version of Lucentis®. The objective of the study is to demonstrate the comparability of FYB201 and Lucentis® in terms of safety, effectiveness, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD). This condition, known as wet AMD, is one of the primary causes of loss of vision in people over the age of 60 in developed countries. It is estimated that as many as 7.5 million people worldwide suffer from wet AMD. Germany alone has around 450,000 patients with the condition.
Lucentis® is a leading drug for the treatment of neovascular age-related macular degeneration. It inhibits the vascular endothelial growth factor (VEGF) responsible for the excessive formation of blood vessels in the retina, which leads to a progressive loss of vision. The total market volume for intraocular anti-VEGF treatments in 2015 was around US$ 7.5 billion, and is growing rapidly.
Dr. Björn Capsius, Director Clinical Development at Formycon, said: “We are delighted that, after intensive preparations, our study has now started to enroll its first patient. It is a major step forward in the development of our biosimilar and we will gain important data supporting the regulatory approval in the EU and US.”
Dr. Joachim Kiefer, Head of Clinical Development at bioeq, added: “The active ingredient ranibizumab is an effective and proven therapy for the treatment of age-related macular degeneration. By developing a high-quality and cost-effective biosimilar, we want to give as many patients as possible the opportunity to access this treatment option. This not only helps improve patient care, but also helps to reduce healthcare costs.”
At the end of 2013, Formycon licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen. bioeq GmbH, a subsidiary of Santo Holding GmbH, is the sponsor of the Phase III study and is also responsible for the global marketing and licensing of FYB201.
* Lucentis is a registered trademark of Genentech 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 an innovative COVID-19 drug.
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. 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.