Formycon AG (FYB.DE) and Zydus Lifesciences have signed an exclusive licensing and supply agreement for FYB206, Formycon's biosimilar to Keytruda, covering the U.S. and Canada.
Formycon will complete development, compile the regulatory dossier, and file the BLA, while Zydus will manage commercialization. FYB206 is nearing the end of its clinical phase, with primary endpoint data expected in early 2026.
Formycon CEO Dr. Stefan Glombitza said the partnership is a major milestone, noting Zydus' strong U.S. commercial footprint and its proven ability to launch complex FDA-approved medicines. Dr. Sharvil P. Patel, Managing Director of Zydus, said the collaboration marks the company's entry into the North American biosimilar market and complements its planned acquisition of Agenus' California manufacturing facilities.
Under the agreement, Formycon will receive mid-teens-million-euro upfront and milestone payments in 2025, plus additional development and regulatory milestones totaling a mid-double-digit-million-euro range. Once launched, Formycon will earn a mid-double-digit share of gross profits. With Keytruda generating US$29.5 billion in 2024, both companies see strong demand for an affordable alternative to pembrolizumab.
FYB.DE currently trades at €24, or 3.61% lower on the XETRA.
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