Overview
- Formycon will finish development, prepare the regulatory dossier, file for approval, and supply FYB206, while Zydus leads commercialization in the U.S. and Canada.
- Formycon becomes eligible for mid-teens-million-euro upfront and 2025 milestone payments, with additional development and regulatory milestones totaling a mid–double-digit–million–euro range.
- Upon market launch in the covered territories, Formycon is slated to receive a mid–double-digit share of gross profits.
- Primary endpoint results for FYB206 are expected in the first quarter of 2026, followed by a planned biologics license application submission to the FDA.
- Zydus describes the agreement as its entry into North American biosimilars and plans to leverage a proposed acquisition of Agenus’s California facilities for future manufacturing, targeting a market led by Keytruda’s $29.5 billion in 2024 sales.