Munich – Formycon AG, Munich, Germany, and bioeq GmbH, Holzkirchen, Germany, today announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis®). The global clinical trial is designed to confirm biosimilarity with regard to safety, efficacy and immunogenicity of FYB201 versus Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The study design was developed in consultation with the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) and is expected to support the registration in both regions.
Top selling eye drug Lucentis® is the leading treatment for nAMD and other eye diseases and had estimated sales of $4.1 billion in 2014. It inhibits vascular endothelial growth factor (VEGF) which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The current total market size for intraocular anti-VEGF therapy is about $6.9 billion.
Formycon had licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen, Germany end of 2013. bioeq GmbH, an affiliate of Santo Holding GmbH, acts as the sponsor of the Phase III study and will also be responsible for the global commercialization and licensing of FYB201.
Carsten Brockmeyer, Ph.D., CEO Formycon AG: “We believe that we are the first company initiating a pivotal phase III study for a biosimilar version of ranibizumab. This underlines our mission to provide high quality biologics to patients across the world. I am glad that Formycon and bioeq will jointly drive the clinical development, regulatory filings and commercialization of FYB201, which will help us to become a significant player in the field of ophthalmological diseases, one of the most rapidly growing therapeutic areas. We continue to advance our pipeline with two other biosimilar candidates already in preclinical phase.”
“Intraocular anti-VEGF agents are a cornerstone in the treatment of age related macular degeneration and other eye diseases. A high quality and clinically proven biosimilar version of Lucentis® could play an important role in broadening the access to these essential medicines and generating much needed savings” said Professor Dr. O. Findl, Chair of the Department of Ophthalmology at Hanusch Hospital, Vienna.
“The costs associated with the treatment of eye diseases have become a tremendous emerging challenge for global health care systems. I am confident that, together with our partner Formycon, we can build a strong global presence in ophthalmology. Biosimilars like FYB201 will address the need for affordable access to essential high-quality treatments for payors, prescribers and patients. We continue to expand our biosimilar portfolio in ophthalmology but also in other indications” said Nicola Mikulcik, CEO of bioeq GmbH.
* 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 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 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.