Formycon expands AI and digital tools across biosimilar development

On October 6, 2026, Formycon said it is incorporating AI and other digital tools into biosimilar development to improve efficiency and scalability under its FYB4GROWTH strategy.

The company is introducing PhlexTMF Enterprise, an AI-assisted electronic trial master file system from Phlexglobal, as a central platform for current and future clinical development. It is also migrating existing trial documentation to the system.

Formycon says the platform is intended to streamline clinical-trial documentation and support quality and regulatory-compliance processes.

Separately, Formycon has introduced AI software to analyze manufacturing-process data. The company says it can help improve collaboration with contract manufacturers and provide structural predictions to support assessment of critical quality attributes.

The initiative aligns with FYB4GROWTH’s focus on cost efficiency:
streamlined processes and greater use of digital technologies are intended to make development more scalable and strengthen competitiveness.