19 Dec 2025

Norton Rose Fulbright Advises Zydus on Strategic Partnership with Formycon for Exclusive US and Canada Licensing and Supply of Oncology Biosimilar

"Norton Rose Fulbright advised Zydus Lifesciences Global FZE on its strategic licensing and supply agreement with Formycon AG for FYB206, a biosimilar to a major oncology monoclonal antibody. Under the deal, Formycon will complete development, prepare and file regulatory dossiers and supply the product, while Zydus will commercialize the biosimilar in the United States and Canada."

Norton Rose Fulbright advised Zydus Lifesciences Global FZE in its strategic partnership with Formycon AG for the exclusive licensing and supply of a biosimilar in the United States and Canada. The transaction concerns FYB206, a biosimilar to a major humanized monoclonal antibody in the field of oncology. The reference product is an immune checkpoint inhibitor used to treat a variety of tumours and, owing to its broad range of oncology indications, is among the world’s best‑selling medicines, underlining significant global demand and market potential. Under the licensing and supply agreement, Formycon will finalise development, prepare and file the regulatory dossier and supply the biosimilar product. Zydus will assume responsibility for the commercialization of the biosimilar in the United States and Canada. Norton Rose Fulbright represented client(s) Zydus Lifesciences Global FZE with a team composed by: Dr Heiko Bertelmann — Lead partner, Corporate/M&A (Hamburg), Head of Life Sciences and Healthcare EMEA; Marcel Gießler — Associate, Corporate/M&A (Hamburg); Clemens Rübel — Partner, Intellectual Property (Munich); Maximilian Schmitz — Senior Associate, Intellectual Property (Munich); Dr Tim Schaper — Partner, Antitrust Law (Hamburg).
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