Formycon receives FDA approval for FYB203/ AHZANTIVE) (aflibercept-mrbb), a biosimilar to Eylea
July 1, 2024 – Pharmaceutical – Formycon, approval, biosimilars, opthamology
1 July 2024, Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its licencing partner
Klinge Biopharma GmbH (“Klinge”) jointly announce that the U.S. Food and Drug Administration (“FDA”)
approved FYB203/AHZANTIVE (aflibercept-mrbb), a biosimilar to Eylea, on June 28, 2024.
Dr. Stefan Glombitza, CEO of Formycon AG, commented: “The FDA approval of FYB203/AHZANTIVE
is another key milestone on our way to becoming the leading pure-play biosimilar developer. It
highlights the expertise and experience of our team. With the Eylea biosimilar FYB203/AHZANTIVE
and our already approved Lucentis biosimilar FYB201, we have achieved an outstanding position in
ophthalmic biosimilar therapies. We are thus improving healthcare for patients with retinal diseases by
offering effective, safe and, above all, affordable treatment options.”
FYB203/AHZANTIVE obtained FDA approval for the treatment of patients with Age-Related
Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic
Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein
Occlusion (RVO). The active ingredient inhibits the vascular endothelial growth factor (“VEGF”), which is
responsible for the excessive formation of blood vessels in the retina. In 2023, Eylea reached global
sales of around US$ 9 bn), confirming its status as the currently best-selling drug in the field of antiVEGF therapies.
The FDA approval for FYB203/AHZANTIVE is based on a thorough evaluation of our comprehensive
data package including analytical, pre-clinical, clinical and manufacturing data. FYB203/AHZANTIVE
demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug
Eylea in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD).
In addition, a marketing authorisation application for FYB203 was submitted to the European Medicines
Agency (“EMA”) at the end of 2023. A decision by EMA is expected by early 2025 at the latest.
About Formycon: Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology,
immunology, immuno-oncology and other key disease areas, covering almost the entire value chain
from technical development through clinical trials to approval by the regulatory authorities. For
commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships
worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and
the USA. Another five biosimilar candidates are currently in development. With its biosimilars, Formycon
is making an important contribution to providing as many patients as possible with access to highly
effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the
Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Visit: https://www.formycon.com
