EQS-News: Formycon secures U.S. License Date for proposed Aflibercept Biosimilar FYB203 following settlement and license agreement with Regeneron

Press Release // October 2, 2025

Formycon secures U.S. License Date for proposed Aflibercept Biosimilar FYB203 following settlement and license agreement with Regeneron

• Formycon and its partners entered into a settlement and license agreement with Regeneron for FYB203/AHZANTIVE^® (Aflibercept-mrbb)
• Pending litigation at the U.S. District Court for the Northern District of West Virginia fully resolved
• Commercial launch of FDA approved FYB203 in the U.S. expected in Q4/2026 by commercialization partner Valorum Biologics

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”), together with its license partner Klinge Biopharma GmbH (“Klinge”) and Valorum Biologics (“Valorum”), announces a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”), resolving all patent disputes related to its FDA-approved Eylea^®2 biosimilar for the U.S. market. Under the terms of the agreement, Valorum may launch AHZANTIVE^® in the United States in the fourth quarter of 2026, or potentially earlier under certain circumstances.

“This agreement marks a significant milestone for Formycon and our partners. It resolves all outstanding patent matters and establishes a clear timeline for the U.S. launch of FYB203/AHZANTIVE^®. Together with Valorum Biologics, our exclusive commercialization partner, we are committed to ensuring that patients and healthcare providers in the United States gain access to a high-quality, affordable biosimilar option for retinal diseases. This achievement highlights our ability to navigate complex regulatory and legal frameworks and reinforces our dedication to expanding patient access in the U.S. market,” says Nicola Mikulcik, Chief Business Officer of Formycon AG.

Regeneron initiated patent infringement proceedings against Formycon in connection with AHZANTIVE^® pursuant to the Biologics Price Competition and Innovation Act (BPCIA) in the US Federal District Court for the Northern District of West Virginia in November 2023. This included infringement claims under about 40 patents protecting the reference product Eylea^® and expiring as late as 2040. All pending litigation has now been resolved by the parties in the agreement.

FYB203/AHZANTIVE^® received FDA approval in July 2024 for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) and other serious retinal diseases, including diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). The active ingredient, aflibercept, inhibits vascular endothelial growth factor (VEGF), targeting abnormal blood vessel formation in the retina.

In June 2025, Formycon announced an exclusive license agreement between Klinge and U.S. biosimilars specialist Valorum for the commercialization of FYB203/AHZANTIVE^® in the United States and Canada.

1) AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
2) Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.

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 and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline 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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection indices. Further information can be found at: https://www.formycon.com/

About Valorum Biologics:
Valorum provides best-in-class execution for the regulatory approval, launch and commercialization of biosimilars in the U.S. The Valorum team brings unparalleled experience and established networks across the U.S. pharmaceutical market and is focused on optimizing commercialization in order to improve access, reach and cost savings for the healthcare system. For further information please visit: www.valorum.bio.

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller
Director Investor Relations and Corporate Communications
Formycon AG
Fraunhoferstr. 15
82152 Martinsried/Planegg
Germany

phone +49 (0) 89 - 86 46 67 149
fax + 49 (0) 89 - 86 46 67 110
Mail: sabrina.mueller@formycon.com

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.