The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the marketing authorization of FYB203, a biosimilar candidate to aflibercept. FYB203 is to be approved in Europe for treating adult patients with age-related neovascular macular degeneration (nAMD) and other retinal diseases such as diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularization (CNV), and macular edema following retinal vein occlusion (RVO). The approval of FYB203 will go by the trade names AHZANTIVE and Baiama in the European Union (EU) and the CHMP’s scientific assessment report forms the basis for the European Commission’s decision to grant a central marketing authorization valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway, to be expected in the second half of January 2025.
The new biosimilar is owned by Formycon AG (FSE: FYB, Prime Standard) and its licensing partner Klinge Biopharma GmbH (Klinge), based in Martinsried-Planegg, a suburb of Munich, and Bayern, Germany, respectively. The preclinical study with FYB203 is an alternative formulation able to demonstrate comparable intraocular pharmacokinetics to the reference product (aflibercept). Formycon completed the development of an efficient process to manufacture the drug and in May 2015, the company signed an agreement to out-license FYB203 to Santo Holding (Deutschland) GmbH, which transferred the worldwide marketing rights for FYB203 within the Santo Group to Klinge Biopharm GmbH. Within the framework of agreement, Formycon will participate in future product sales through corresponding royalties.
According to the company, aflibercept is a recombinant human fusion protein which works by binding to vascular endothelial growth factor (VEGF-A), as well as to placental growth factor (PLGF). Through this action, aflibercept suppresses the formation of blood vessels in the retina, and, like Lucentis, Eylea is injected directly into the vitreous body of the eye. Due to their different mechanisms of action, aflibercept and ranibizumab complement each other very well in clinical practice. Some patients respond better to aflibercept, while others see more benefit from ranibizumab. The company has commented that aflibercept and ranibizumab make up more than 90% of the world market for anti-VEGF therapies while in 2023, Eylea alone generated USD 9.2 billion in sales.
Following the approval of FB203 ay the CHMP (EMA), Dr. Stefan Glombitza, CEO of Formycon AG, commented: “We are excited about the positive CHMP opinion for FYB203, our biosimilar candidate to Eylea®. As our second ophthalmic biosimilar therapy following the success of our Lucentis® biosimilar, FYB203 represents a further advancement in treatment options for serious retinal diseases. After FDA approval in June, this milestone is a testament to the expertise, dedication and hard work of the entire Formycon team and underscores our commitment to enhancing patient care through affordable alternatives. We are now awaiting European Commission approval in the second half of January 2025 and look forward to offering patients a high-quality treatment option that can improve their quality of life.”
Dr. Glombitza directed the operational development activities at Formycon as Chief Operating Officer (COO) before being appointed Chief Executive Officer (CEO) with effect from July 01, 2022. In his role as CEO, Dr. Glombitza shapes Formycon’s strategic direction in an increasingly commercial phase of its corporate development and, together with his team of experts, drive forward with a continuously expanding portfolio of products and development projects.