Formycon and Zydus Forge Licensing Agreement for FYB206 in North America

Formycon AG has announced a strategic alliance with Zydus Lifesciences for the exclusive licensing and supply of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada. Zydus, an experienced commercial entity with over 225 FDA-approved drugs, will handle FYB206's market introduction. The partnership involves mid-teens-million-euro upfront and milestone payments in 2025, with potential further earnings from regulatory milestones and a share of gross profits post-launch.

The clinical development of FYB206 is nearing completion, with primary endpoint data expected in early 2026. This collaboration underscores both companies' confidence in their biosimilar development capabilities. Pembrolizumab serves various tumors with significant market demand. Upon finalizing the FDA application, Formycon seeks to expand access to affordable oncology treatments, leveraging Zydus' commercial strength in North America.