Formycon AG and its licensing partner Klinge Biopharma GmbH announced that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea, under the brand names AHZANTIVE® and Baiama®. This approval marks a significant step in providing cost-effective alternatives for treating serious retinal diseases.
The approval encompasses the treatment of neovascular (wet) age-related macular degeneration (nAMD) and other severe retinal conditions, including Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularisation (CNV), and Macular Edema following Retinal Vein Occlusion (RVO). The decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in November 2024.
Expanding Treatment Options for Retinal Diseases
Dr. Stefan Glombitza, CEO of Formycon AG, stated, "The EU approval of FYB203, our biosimilar for Eylea®, marks another milestone for Formycon and is based on the expertise and dedication of our entire team. As our second ophthalmic biosimilar, FYB203 significantly expands therapeutic options for patients with severe retinal diseases. With AHZANTIVE® and Baiama®, we are improving access to high-quality and affordable therapies that contribute sustainably to enhancing patients’ quality of life."
Aflibercept functions by inhibiting the vascular endothelial growth factor (VEGF), a key factor in the excessive formation of blood vessels in the retina that impairs vision. The reference product, Eylea®, achieved approximately USD 9 billion in global sales in 2023, underscoring the need for a cost-effective alternative like FYB203.
Commercialization and Market Access
In mid-January 2025, Formycon and Teva Pharmaceuticals International GmbH (Teva) entered a licensing agreement for the semi-exclusive commercialization of FYB203 across major parts of Europe and Israel. Formycon has also finalized a product supply agreement with Teva. FYB203 received approval from the U.S. Food and Drug Administration (FDA) in June 2024, further validating its potential impact.
With the EU approval, AHZANTIVE® and Baiama® are poised to offer a high-quality, more accessible treatment option for patients suffering from nAMD, DME, and other retinal vascular disorders, potentially reducing healthcare costs and improving patient outcomes.
