Formycon sets Benchmark in Biosimilar Development: Scientific Foundation of the innovative Development Program for FYB206 published in the Journal BioDrugs

Press Release // September 22, 2026

Formycon sets Benchmark in Biosimilar Development:
Scientific Foundation of the innovative Development Program for FYB206 published in the Journal BioDrugs

• Peer-reviewed journal BioDrugs has published a scientific article on Formycon’s innovative scientific concept for a streamlined clinical development approach for Keytruda^®1 biosimilar candidate FYB206
• Publication underlines Formycon’s pioneering role in implementing a regulatory and scientifically grounded pharmacokinetic (PK)-focused development program
• Article demonstrates how modern analytics, functional testing methods, and pharmacokinetics can gradually replace traditional clinical efficacy studies in biosimilar development
• Clinical development of FYB206 successfully completed in July 2026

Planegg-Martinsried, Germany, September 22, 2026 – Formycon AG (FSE: FYB, Prime Standard, “Formycon”) announces the publication of the scientific article “From Reflection to Implementation – Tailored Clinical Development of a Pembrolizumab Biosimilar Candidate” in the peer-reviewed journal BioDrugs. The article describes the scientific and regulatory principles of a modern, evidence-based developmental approach for biosimilars using the example of the pembrolizumab biosimilar candidate FYB206 to illustrate how a PK-focused clinical development program can be successfully implemented. This publication reflects the current shift in regulatory science: International health authorities such as the European Medicines Agency (EMA), the U.S. FDA, and other leading regulatory agencies are recognizing that modern analytical methods, sensitive functional assays, and comparative PK studies can provide greater insight for well-characterizable biologics than traditional comparative efficacy studies. Using FYB206 as an example, the article illustrates how this science-based approach can be implemented in practice without compromising quality, safety, or efficacy.

Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG, said: “In line with our FYB4Growth strategy, FYB206 demonstrates the successful implementation of a science-driven and forward-looking clinical development strategy. We believe that PK-focused clinical approaches have the potential to reshape biosimilar development in a lasting way. Formycon recognized the potential of this strategy at an early stage and is today among the companies helping to drive its practical implementation. This pioneering role is further underscored by the publication of these findings in the peer-reviewed journal BioDrugs.”

Building on the scientific understanding that modern analytical characterization methods, functional comparability studies, and sensitive PK studies can provide robust evidence of biosimilarity for most biologics, the article describes this optimized clinical strategy using Formycon’s pembrolizumab biosimilar candidate FYB206 as an example. Pembrolizumab is a humanized monoclonal antibody blocking the PD-1 signaling pathway and commonly used for the treatment of various tumor diseases. Due to its well-studied mode of action and its comprehensive analytical characterization, this compound is particularly suited for an optimized development approach.

The publication follows the successful completion of the pivotal DAHLIA study, in which FYB206 demonstrated pharmacokinetic equivalence to the reference drug Keytruda^®. This study highlights the significant potential of PK-focused development programs for future biosimilar development. For suitable biologics, such strategies can help reduce the clinical burden without compromising scientific validity. Thus, Formycon is making an important contribution to the current scientific and regulatory discussion on the further development of efficient biosimilar development programs.

The publication is available at https://doi.org/10.1007/s40259-026-00803-y.

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¹ Keytruda^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ/USA.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company covers the entire value chain, from the selection of a promising biosimilar candidate through the various stages of development to the delivery of the approved and market-ready product. In addition, Formycon also has extensive expertise in the planning, management, and monitoring of the supply chain as well as international product logistics. For the commercialization of its biosimilars, Formycon relies on strong, trusted and long-term partnerships worldwide. With FYB201/ranibizumab, FYB202/ustekinumab and FYB203/aflibercept, Formycon already has three biosimilars on the market. Four pipeline candidates – including FYB206/pembrolizumab and 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/en/

About #FYB4Growth
With FYB4Growth, Formycon is pursuing a growth strategy based on four strategic pillars aimed at creating sustainable value. First, geographic diversification: in addition to Europe and the U.S., Formycon is strategically expanding into high growth regions such as MENA, APAC and Latin America through strong regional partners. Second, a smart portfolio strategy: Formycon relies on an intelligent portfolio strategy that specifically combines blockbuster molecules with selected niche products and creates the foundation for sustainable value generation through efficient regulatory development pathways. Third, excellence and innovation: Formycon positions itself as a technological and regulatory development powerhouse, creating clear competitive differentiation through innovative product solutions and new regulatory approaches. Fourth, consistent cost efficiency: streamlined processes, optimized development structures and the increased use of digital technologies are designed to enhance the scalability of the business model and strengthen Formycon’s competitiveness over the long term. Find out more at: https://www.fyb4growth.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:
Pamela Keck
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Phone:  +49 (0) 89 - 86 46 67 369
Fax: +49 (0) 89 - 86 46 67 110
Email: ir@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.