EQS-News: Formycon achieves key development milestone with FYB208: Biosimilar candidate for Dupixent® (dupilumab) adds another growth driver to the biosimilar portfolio

Press Release // November 17, 2025
 

Milestone achieved with FYB208: Biosimilar candidate for Dupixent® (dupilumab) as another growth driver in Formycon's portfolio

• Important preclinical milestone Technical Proof of Similarity (TPoS) demonstrates high analytical comparability of FYB208 to reference drug
• Strong in vitro data support cost-effective development and streamlined clinical development program
• Immunological biosimilar candidate FYB208/Dupilumab will address a rapidly growing market and is expected to provide patients with chronic inflammatory diseases such as COPD, asthma, and atopic dermatitis with greater access to highly effective therapy
   

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) today announced details of one of its previously undisclosed development projects: FYB208 is a biosimilar candidate for the immunological blockbuster drug Dupixent^®1 (INN: dupilumab). With successful demonstration of the Technical Proof of Similarity (TPoS), FYB208 shows high analytical comparability to the reference drug.

Dupilumab is used to treat certain patients with chronic obstructive pulmonary disease (COPD), asthma, atopic dermatitis (neurodermatitis), and other chronic inflammatory diseases. The active ingredient inhibits the signaling pathways of interleukin-4 (IL-4) and IL-13, which are responsible for type 2 inflammatory reactions. Due to its wide range of therapeutic opportunities with approvals for additional indications, the active ingredient has been recording high growth rates for years. In 2024, global sales reached US$14.1 bn, an increase of 22% compared to the previous year.² In 2025, growth continued at a similar rate: Dupixent^® generated revenues of around US$8 bn in the first six months.³ Forecasts underscore the sustainably high potential of dupilumab: sales are expected to rise to more than US$ 20 bn⁴ by 2030.

Dr. Andreas Seidl, CSO of Formycon AG, commented: "With the achieved Technical Proof of Similarity, we successfully completed the preclinical development of our dupilumab biosimilar candidate. The convincing data on its comparability with the reference drug highlights our strong expertise in development of biosimilars, especially in chronic inflammatory diseases and marks another important milestone in our growth strategy. Based on this excellent data set, we are highly confident that we will be able to meet all requirements for approval of FYB208 without a comparative efficacy study (Phase III study). This allows us to advance development with an optimized timeline, in order to improve access to a much-needed treatment option for the many patients suffering from chronic inflammatory diseases. This is supported by the high productivity of the developed cell line, which enables competitive manufacturing.”

¹ Dupixent^® is a registered trademark of Sanofi Biotechnology.
²Regeneron Reports Fourth Quarter and Full Year 2024 Financial and Operating Results; Initiates Quarterly Dividend and Increases Total Share Repurchase Capacity to ~$4.5 Billion | Regeneron Pharmaceuticals Inc.
³Regeneron Reports Second Quarter 2025 Financial and Operating Results | Regeneron Pharmaceuticals Inc.
⁴Press Release: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025
⁵Reflection paper on a tailored clinical approach in biosimilar development; EMA/CHMP/BMWP/60916/2025
⁶ FDA guidance for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated
  Recommendations for Assessing the Need for Comparative Efficacy Studies. https://www.fda.gov/media/189366/download

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 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

Tel.: +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.