EQS-News: NTC becomes commercialization partner for Formycon’s Eylea® biosimilar FYB203/Baiama® in Italy

Press Release // November 24, 2025
 

NTC becomes commercialization partner for Formycon’s Eylea^® biosimilar FYB203/Baiama^® in Italy
 

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and NTC s.r.l. (“NTC”) jointly announce that Klinge Biopharma GmbH (“Klinge”), the exclusive owner of the global commercialization rights of Formycon's Eylea^®1 biosimilar FYB203 (aflibercept), concluded an exclusive agreement with NTC for the commercialization of FYB203/Baiama^®2 in Italy.

As part of the agreement, Klinge is eligible to receive royalties on net sales. Formycon will participate in the mid-single-digit to low-double-digit percentage range in all payment streams to Klinge. Furthermore, Formycon will act as authorized designee to organize the supply chain for FYB203 and will receive additional service payments and a volume-based profit component for organizing the commercial market supply on behalf of Klinge.

Nicola Mikulcik, CBO of Formycon AG commented: „Age-related diseases such as wet macular degeneration (“nAMD”) are on the rise in Europe due to the continuously increasing number of people over the age of 65. Our Eylea^® biosimilar FYB203 provides ophthalmologists with a safe, effective and cost-efficient treatment option for such serious conditions. For Italy, we are very pleased to present NTC as our partner for the exclusive distribution of FYB203/Baiama^®. NTC is a local specialist in ophthalmology with a deep understanding of the specific market landscape and a strong customer network.“

NTC is a leading R&D driven pharmaceutical company based in Italy with a strong focus on disease areas like ophthalmology, gastroenterology, pediatrics, and gynecology. The company’s growing portfolio consists of brand R_X products, generic and biosimilar drugs, nutraceuticals and medical devices.

In June 2024, the aflibercept biosimilar FYB203 was approved by the US Food and Drug Administration (“FDA”). Approval by the European Commission under the brand names AHZANTIVE^®3 and Baiama^® followed in January 2025.^{One month later FYB203 also received marketing authorization by the British MHRA.4}

Eylea^® (aflibercept) is used to treat nAMD and other severe retinal diseases. The active ingredient inhibits vascular endothelial growth factor (“VEGF”), which is responsible for the excessive formation of blood vessels in the retina.

-----------------------

¹⁾  Eylea^® is a registered trademark of Regeneron Pharmaceuticals Inc.
²⁾  Baiama^® is a registered trademark of Klinge Biopharma GmbH
³⁾  AHZANTIVE^® is a registered trademark of Klinge Biopharma GmbH
⁴⁾  The commercial launch of FYB203 in Europe depends on the progress and
outcome of ongoing or potential future patent litigation or possible settlement
agreements.

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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX selection index. Further information can be found at: https://www.formycon.com/

About NTC:
NTC is a pharmaceutical company based in Milan, with products available in over 100 countries through a network of distributors and partners. NTC is engaged in the research, development, registration and marketing of drugs, medical devices and food supplements in the field of ophthalmology, as well as in other therapeutic areas such as pediatrics, gynecology and gastroenterology.

NTC offers more than 250 partners innovative pharmaceutical products of the highest quality standards. Further information at www.ntcpharma.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 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
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.