Formycon successfully completes patient enrollment for the clinical development of its Keytruda® biosimilar candidate FYB206

Streamlined clinical development program, which no longer requires a Phase III trial, is already in a far advanced stage
Last patient enrolled in Dahlia pharmacokinetic (PK) study (Last Patient-In)
First patients have completed all 17 treatment cycles of the Dahlia study
Results on the primary endpoint of the study expected in the first quarter of 2026

Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) announced today that the patient enrollment for the clinical PK study Dahlia¹ has been successfully completed with a total of 96 participants (Last Patient-In). The Dahlia study, which was launched in June 2024 in selected Southeastern and Eastern European study centers, compares the pharmacokinetics, safety and tolerability of FYB206 with the immuno-oncology blockbuster drug Keytruda^®2.

At the end of 2024, Formycon submitted a streamlined clinical strategy to the U.S. Food and Drug Administration (FDA) with the intention to demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda^®based on comprehensive analytical data and data from the PK study (Dahlia). Following a positive response from the FDA, the company decided in February 2025 to discontinue recruitment for the already-started Phase III trial. This decision accelerates the development of the biosimilar and at the same time significantly reduces the related investments over the coming years. The treatment of patients already enrolled in the Phase III trial has subsequently been continued with the locally available Keytruda^® outside the trial.

„With our streamlined clinical development program for FYB206, we have secured a leading role among the developers of a pembrolizumab biosimilar. This is further underlined by the efficient and reliable execution of the Dahlia PK study. The fact that we can now announce the completion of patient enrollement with the ‘last patient in’ is further proof of Formycon’s professional study management and the strong recruitment performance in the study centers“, says Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG and adds: „The first patients in the Dahlia trial have already completed all 17 treatment cycles. We therefore currently expect to receive the results of the study endpoint in the first quarter of 2026.

As a reminder: based on our stringent Dahlia study design, our sound scientific rationale and the comprehensive analytical data showing high structural and functional comparability with the reference drug, we have aligned with the FDA on a streamlined clinical development program that allows us to skip the Phase III trial. This approach accelerates development without compromising on quality, safety and efficacy. Furthermore – the streamlined clinical program supports our strategy to provide the pembrolizumab biosimilar FYB206 to patients worldwide as soon as possible and thus improve access to this essential drug.“

Pembrolizumab is an immune checkpoint inhibitor that is used in cancer therapies to treat various tumor diseases. With this broad range of indications and sales of around US$ 29.5 billion in 2024³, Keytruda^® is currently the world’s best-selling drug. Sales could rise even further in the coming years – according to forecasts to over US$ 50 billion in 2032⁴. The number of cancer diagnoses is also continuing to rise – estimates by the International Agency for Research on Cancer (IARC) predict an increase of 77% by 2050^.5

Following the successful completion of clinical development and approval by the regulatory authorities, Formycon currently expects the earliest market entry of its biosimilar candidate FYB206 after the expiry of the market exclusivity of the reference product in 2029 for the USA and after 2030 for the EU.

¹The Dahlia-PK study treats patients who have had malignant melanoma (black skin cancer) surgically removed. This so-called adjuvant therapy over 17 treatment cycles aims to minimize the risk of relapse in these patients.
² Keytruda^®is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.
³Source: https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/
⁴Source: https://www.custommarketinsights.com/report/keytruda-market/
⁵Source: https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services

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 in Europe and the USA. A third biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA; FYB202 is also approved in 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, headquartered in Munich, is 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: 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 providers. 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.

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.

Press & IR Contact
Sabrina Müller
Director Investor Relations and
Corporate Communications
T + 49 89 86 46 67 149
F + 49 89 86 46 67 110
sabrina.mueller@formycon.com

Formycon AG
Fraunhoferstr. 15
82152 Planegg/Martinsried
Germany
www.formycon.com