Formycon secures license date for aflibercept 2 mg biosimilar FYB203 in Europe and further territories following settlement with Regeneron and Bayer

Press Release // March 19, 2026
 

Formycon secures license date for aflibercept 2 mg biosimilar FYB203 in Europe and further territories following settlement with Regeneron and Bayer

• Settlement and licensing agreement for FYB203 (AHZANTIVE^® and Baiama^®) concluded with Regeneron and Bayer; all pending patent litigations fully resolved
• Agreement covers Europe as well as key markets in Latin America and the Asia-Pacific region
• Market launches by commercialization partners across Europe to start in May 2026

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its license partner Klinge Biopharma GmbH (“Klinge”) announce a settlement and license agreement (“Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) and Bayer Healthcare LLC (“Bayer”), resolving all patent disputes related to the EU-approved Eylea^®1 2 mg biosimilars AHZANTIVE^®2 and Baiama^®3. Under the terms of the agreement, both products may be launched in Europe and further territories including key markets in Latin America and Asia-Pacific from May 2026. In October 2025, Formycon had already secured the U.S. license date for FYB203 in Q4 2026 as part of an agreement with Regeneron.

"The agreement for Europe and further territories is a significant milestone, as it secures timely market access for our commercialization partners. With our differentiated and regionally focused partnering strategy, we are sure that we have set the course for sustainable success of FYB203 across the European markets and beyond. For ophthalmologists and patients with severe retinal diseases, our biosimilars represent a highly effective and cost-efficient treatment option," says Nicola Mikulcik, Chief Business Officer of Formycon AG.

AHZANTIVE^® and Baiama^® are approved by the European Medicines Agency (“EMA”) for the treatment of neovascular age-related macular degeneration (“nAMD”) and other serious retinal diseases. The active ingredient aflibercept inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina, causing severe visual impairment.

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¹  Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²  AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
³  Baiama^® is a registered trademark of Klinge Biopharma GmbH

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 – including FYB208/dupilumab – 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 listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/

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 & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Phone +49 (0) 89 - 86 46 67 149
Fax + 49 (0) 89 - 86 46 67 110
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.