Formycon AG and Zydus Lifesciences Limited announced a strategic partnership that grants Zydus exclusive rights to license, supply, and commercialize FYB206, a pembrolizumab biosimilar, in the United States and Canada. Under the agreement, Formycon will finalize development, file the U.S. Biologics License Application, and supply the product, while Zydus will handle commercialization in the two countries.
The licensing fee structure includes a mid‑teens‑million‑euro upfront payment, 2025 milestone payments, and a mid‑double‑digit gross‑profit‑share that will be earned once FYB206 reaches market launch. The deal also aligns with Zydus’ planned acquisition of Agenus Inc.’s California manufacturing facilities, positioning the company to scale production for the North American biosimilar market.
FYB206 is in the final stages of its clinical program, with primary‑endpoint data expected in the first quarter of 2026. Formycon’s streamlined development strategy—eschewing a traditional Phase 3 trial in favor of robust analytical and Phase 1 data—has accelerated the timeline, and the company plans to submit the BLA to the FDA shortly thereafter.
The partnership gives Zydus a foothold in a market dominated by Merck’s Keytruda, which generated more than $29 billion in sales in 2024 and is protected by patents that expire in 2028 in the U.S. and 2030‑31 in Europe. FYB206’s entry could erode Keytruda’s market share, potentially impacting Merck’s future revenue trajectory and accelerating competition in the oncology biosimilar space.
Zydus CEO Dr. Sharvil P. Patel said the collaboration “marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product” and highlighted the synergy with its planned acquisition of Agenus facilities. Formycon CEO Dr. Stefan Glombitza noted that the partnership “strengthens our collective commitment to expanding access to medicines” and underscored Formycon’s confidence in the product’s regulatory pathway.
Investors welcomed the deal, citing the strategic expansion into a high‑growth oncology segment and the potential to challenge a dominant market player. The announcement underscores both companies’ focus on scaling biosimilar development and commercialization in the United States and Canada.
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