• Targeted use of digital technologies, including artificial intelligence, supports Formycon’s lean development approach and strengthens efficiency and competitiveness
  • Introduction of a centralized digital environment for clinical trial documentation using Phlexglobal’s eTMF (electronic trial master file) solution
  • AI-enabled document management system supports process efficiency and Formycon’s quality and compliance processes

Planegg-Martinsried, Germany, October 6, 2026 – Formycon AG (FSE: FYB, Prime Standard; “Formycon”) is enhancing the efficiency and scalability of its biosimilar development activities through the focused use of digital technologies. In line with its FYB4GROWTH strategy, the company is integrating artificial intelligence (AI) and other innovative digital solutions into key development processes to further optimize operational workflows and support sustainable value creation.

One specific example is the introduction of PhlexTMF Enterprise, an electronic trial master file (eTMF) solution with AI-assisted capabilities from Phlexglobal. Trial Master Files are essential to clinical development: They document the design, conduct, and monitoring of clinical trials across several thousand pages and must meet the highest regulatory standards. Formycon is introducing PhlexTMF as the central platform for current and future clinical development activities, while simultaneously migrating existing Trial Master Files from legacy systems to the new environment.

Dr. Andreas Seidl, Chief Scientific Officer of Formycon AG, commented: “Lean Development is a key driver of our FYB4GROWTH strategy: We combine scientific excellence and innovation with financial discipline to increase the efficiency and competitiveness of our development programs. PhlexTMF demonstrates how we leverage new technologies to optimize processes and advance operational workflows. Based on our internal assessment, we expect the implementation of the new system to contribute to efficiency improvements of approximately 20 percent. At the same time, the system supports our processes for maintaining high standards for quality, data integrity, and regulatory compliance. This creates additional scope for value creation and sustainable growth.”

Separately from its implementation of PhlexTMF, Formycon has also identified lean development opportunities in technical and regulatory development. In addition to tailored database systems and the use of flexible apps to manage and evaluate data, the use of artificial intelligence can significantly accelerate time-consuming processes in these domains as well. Specifically, the company has introduced AI-powered software for analyzing manufacturing process data, which is designed to optimize and accelerate collaboration with contract manufacturers and to provide structural predictions that support the evaluation of critical quality attributes.

About Formycon:
Formycon AG is a listed, independent developer of biosimilars based in Martinsried, one of the leading life science locations in Europe, just outside Munich, Germany. Around 200 employees from 27 countries cover the entire development chain, from laboratory analysis through manufacturing and clinical testing to the documents for approval. Three Formycon biosimilars are approved in ophthalmology and immunology and are marketed worldwide through commercialization partners. Four further candidates are in development, among them biosimilars to two of the best-selling biologic medicines in the world. With its products, Formycon makes highly effective therapies affordable for more people.

Formycon shares are listed in the Prime Standard of the Frankfurt Stock Exchange (ticker FYB, ISIN DE000A1EWVY8, WKN A1EWVY). Further information 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 US, 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 the competitiveness of Formycon over the long term. Find out more at: https://www.fyb4growth.com

About Biosimilars:
Biosimilars are successor products to biologic medicines. They are not copies; each one is developed from the ground up and has to prove to the health authorities that it matches the reference product in safety and efficacy. According to the IQVIA Institute, 118 biologic medicines with sales of USD 232 billion will lose their exclusivity in the US alone by 2034, and for only twelve of them is a biosimilar in development. In Europe, biosimilars have saved around EUR 75 billion and made more than seven billion days of treatment possible.

About Phlexglobal:

Phlexglobal is a Trial Master File specialist service provider, helping life sciences organizations improve quality, reduce risk, and achieve continuous inspection readiness through expert services, purpose-built technology, and AI-powered innovation. Phlexglobal combines deep TMF expertise with Trusted Clinical Intelligence to help organizations operate more efficiently and confidently across the clinical trial lifecycle.

 

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.