Formycon Optimizes Biosimilar Development with AI-Powered Technologies: Digital Solutions Enhance Development Efficiency as Part of the FYB4GROWTH Strategy

Formycon AG ("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.

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.”

Dr. Andreas Seidl, Chief Scientific Officer, Formycon AG

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.