Press Release // February 20, 2025
 

Formycon presents clinical data on ustekinumab biosimilar FYB202 at the ECCO Congress in Berlin
 

Planegg-Martinsried, Germany - Formycon AG (FSE: FYB, Prime Standard, “Formycon”) will present an overview of the comparative data of the ustekinumab biosimilar FYB202 at this year's Congress of the European Crohn's and Colitis Organisation (ECCO), taking place in Berlin, Germany, from February 19 to 22, 2025. The poster presentation summarizes the clinical phase I and phase III study results and is complemented by advanced analytical laboratory data demonstrating the comparability of FYB202 with the reference product Stelara^®1.

Using a comprehensive set of analytical methods, the relevant quality characteristics of FYB202 were first examined and its functional comparability with the reference product was assessed in terms of the main mechanism of action using IL-12 and IL-23 binding tests and bioassays. FYB202 was found to be analytically comparable to the reference ustekinumab with respect to physicochemical and biological properties, including structure, function, purity and potency.

The therapeutic equivalence of FYB202 was demonstrated in a Phase I pharmacokinetics (PK) study in 491 healthy volunteers and in a Phase III efficacy study in 392 patients with moderate to severe plaque psoriasis. Based on a totality of evidence approach, these results allow for extrapolation to other approved indications of the reference drug and confirm that FYB202 has a comparable clinical performance to Stelara^® in all indications, making it a safe and highly effective alternative for patients treated with ustekinumab.

Presentation details:

• Session: Guided poster session, February 21, 2025, 12:40 pm – 1:40 pm CET
• Poster-ID: P0879
• Title: The Totality of Evidence for FYB202 – an EU-approved and US-licensed Biosimilar to Reference Ustekinumab
• Room: Poster Exhibition Area
• Date: February 19-22, 2025

FYB202 is an interleukin inhibitor that can be used in dermatology to treat psoriasis and in gastroenterology to treat chronic inflammatory bowel disease. The biosimilar received marketing authorization from the EMA and the FDA in September 2024, and from Health Canada and the UK's MHRA in January 2025.

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1) Stelara^® is a registered trademark of Johnson & Johnson

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, the USA, Canada and parts of the MENA region. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA and European Commission approval; FYB202 is also approved in the UK and Canada. Another four 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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY and is part of the SDAX and TecDAX selection indices. Further information can be found at: www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment ofserious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including45 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.